Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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Dr Mohan Z Mani

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Believers Church Medical College,
Thiruvalla, Kerala
On Sep 2018




Prof. Somashekhar Nimbalkar

"Over the last few years, we have published our research regularly in Journal of Clinical and Diagnostic Research. Having published in more than 20 high impact journals over the last five years including several high impact ones and reviewing articles for even more journals across my fields of interest, we value our published work in JCDR for their high standards in publishing scientific articles. The ease of submission, the rapid reviews in under a month, the high quality of their reviewers and keen attention to the final process of proofs and publication, ensure that there are no mistakes in the final article. We have been asked clarifications on several occasions and have been happy to provide them and it exemplifies the commitment to quality of the team at JCDR."



Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
Ex-President - National Neonatology Forum Gujarat State Chapter
Department of Pediatrics, Pramukhswami Medical College, Karamsad, Anand, Gujarat.
On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Professor and Head
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Sri Devaraj Urs Medical College
Sri Devaraj Urs Academy of Higher Education and Research , Kolar, Karnataka
On Sep 2018




Dr. Saumya Navit

"As a peer-reviewed journal, the Journal of Clinical and Diagnostic Research provides an opportunity to researchers, scientists and budding professionals to explore the developments in the field of medicine and dentistry and their varied specialities, thus extending our view on biological diversities of living species in relation to medicine.
‘Knowledge is treasure of a wise man.’ The free access of this journal provides an immense scope of learning for the both the old and the young in field of medicine and dentistry as well. The multidisciplinary nature of the journal makes it a better platform to absorb all that is being researched and developed. The publication process is systematic and professional. Online submission, publication and peer reviewing makes it a user-friendly journal.
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Dr Saumya Navit
Professor and Head
Department of Pediatric Dentistry
Saraswati Dental College
Lucknow
On Sep 2018




Dr. Arunava Biswas

"My sincere attachment with JCDR as an author as well as reviewer is a learning experience . Their systematic approach in publication of article in various categories is really praiseworthy.
Their prompt and timely response to review's query and the manner in which they have set the reviewing process helps in extracting the best possible scientific writings for publication.
It's a honour and pride to be a part of the JCDR team. My very best wishes to JCDR and hope it will sparkle up above the sky as a high indexed journal in near future."



Dr. Arunava Biswas
MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




Dr. C.S. Ramesh Babu
" Journal of Clinical and Diagnostic Research (JCDR) is a multi-specialty medical and dental journal publishing high quality research articles in almost all branches of medicine. The quality of printing of figures and tables is excellent and comparable to any International journal. An added advantage is nominal publication charges and monthly issue of the journal and more chances of an article being accepted for publication. Moreover being a multi-specialty journal an article concerning a particular specialty has a wider reach of readers of other related specialties also. As an author and reviewer for several years I find this Journal most suitable and highly recommend this Journal."
Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
Timely publication of journal: Publication of manuscripts and bringing out the issue in time is one of the positive aspects of JCDR and is possible with strong support team in terms of peer reviewers, proof reading, language check, computer operators, etc. This is one of the great reasons for authors to submit their work with JCDR. Another best part of JCDR is "Online first Publications" facilities available for the authors. This facility not only provides the prompt publications of the manuscripts but at the same time also early availability of the manuscripts for the readers.
Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2022 | Month : June | Volume : 16 | Issue : 6 | Page : UC33 - UC37 Full Version

Comparing the Effectiveness of Ambu® AuraGain™ Laryngeal Mask Airway with LMA® ProSeal™ in Patients Undergoing Laparoscopic Surgeries- A Randomised Clinical Trial


Published: June 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/56407.16481
MK Manisha, Archana Anilkumar Bharadwaj, Shyamsunder Kamath

1. Senior Resident, Department of Anaesthesia, ESIC Medical College, PGIMSR and Model Hospital, Rajajinagar, Bengaluru, Karnataka, India. 2. Assistant Professor, Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India. 3. Professor, Department of Anaesthesiology, SDM College of Medical Sciences and Hospital, Dharwad, Karnataka, India.

Correspondence Address :
Dr. Archana Anilkumar Bharadwaj,
Plot No.4, Shakambari, 2nd Main, 2nd Cross, Vidyagiri, Dharwad-580004, Karnataka, India.
E-mail: archana.a.b16@gmail.com

Abstract

Introduction: Second generation Supraglottic Airway Devices (SADs) contain a gastric drain tube which separates the respiratory and the alimentary tract. This provides a better oropharyngeal seal and reduces the risk of pulmonary aspiration of refluxed gastric contents compared to the first generation SADs.

Aim: To compare Ambu® AuraGain™ (AAU) laryngeal mask airway with LMA® ProSeal ™ (PLMA) in terms of Oropharyngeal Leak Pressure (OLP) in laparoscopic surgeries.

Materials and methods: This randomised clinical study was conducted from December 2017 to September 2019, at Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad, India in 80 patients, aged 18 to 65 years, of American Society of Anesthesiologists (ASA) physical status I and II undergoing laparoscopic surgeries. Patients were randomly assigned to one of the two groups: group PLMA and group AAU. After induction of anaesthesia, SADs were inserted by an experienced anaesthesiologist. OLP, pharyngeal mucosal pressure, peak airway pressure and secondary outcome parameters (the number of attempts, time required, ease, and hemodynamic response associated with insertion of LMA) were recorded at set time points. Data was analysed using Statistical Packages for Social Sciences (SPSS) version 22.

Results: All patients in both the groups were comparable in terms of demographic data and baseline vital parameters. The Oropharyngeal Leak Pressure of group AAU was comparable to group PLMA at all measured time-points. The two groups were comparable in terms of pharyngeal mucosal pressure immediately after insertion of LMA, but group AAU had lesser pharyngeal mucosal pressure compared to group PLMA immediately after pneumoperitoneum, at 30 and 60 minutes. Mean peak airway pressures were lower in group AAU than group PLMA immediately after insertion of LMA (15.53±1.50 versus 17.06±2.56 cmH2O, p=0.004) and immediately after creation of pneumoperitoneum (23.03±2.96 versus 23.03±2.96 cmH2O, p= 0.04). Both the groups were comparable in terms of number of attempts, time taken, haemodynamic response associated with LMA insertion and with passage of gastric tube except that PLMA was easier to insert in the first attempt compared to AAU (26/40 versus 13/40, Grade 1 ease of insertion).

Conclusion: Ambu® AuraGain™ could be a useful alternative to LMA® ProSeal ™ in patients undergoing laparoscopic surgeries.

Keywords

Airway pressure, Oropharygeal leak pressure, Pharyngeal mucosal pressure, Supraglottic airway devices

Laparoscopic surgeries have gained popularity over conventional abdominal surgeries due to various advantages like smaller incision, lower risk of postoperative complications and early discharge. However, intraoperatively the effect of pneumoperitoneum and subsequent alteration in the respiratory volumes and pressures are the major concerns in laparoscopic surgery (1). Laparoscopic surgeries are usually done under general anaesthesia with the airway secured using an endotracheal tube. Rigid laryngoscopy associated haemodynamic responses, damage to the oropharyngeal structures during intubation, and invasiveness are some disadvantages associated with endotracheal intubation precluding the global utility of the endotracheal tube (2). Hence there is a need for better alternatives such as Supraglottic Airway Devices (SADs) (3). The second generation SADs incorporate a gastric drain tube in their construction to separate the respiratory and alimentary tract offering better oropharyngeal seal and improved protection against regurgitation and pulmonary aspiration in comparison to first generation SADs (4).

LMA® ProSeal™ (PLMA) (Intavent Orthofix, Maidenhead, UK) has a basic structure similar to the classic laryngeal mask airway. In addition, it was designed with modifications to separate the respiratory and gastro intestinal tract by incorporating a gastric drain tube, thus offering improved protection against aspiration of gastric contents. The design also incorporates a second, dorsal cuff to improve airway seal, improve safety and efficacy of controlled ventilation (5). Ambu® AuraGain™ (AAU) launched in 2014, is a newer single use second generation SAD. It has a preformed tube designed to follow the anatomy of the human airway, and the soft rounded curve allows easy insertion and a low friction surface of the drain tube allows for easy gastric tube placement (6). A study compared Ambu® AuraGain™ with LMA® ProSeal™ in patients undergoing laparoscopic surgeries (7), especially the OLP, but it did not perform repeated measurements throughout the procedure, which is unique to the present study.

The aim of the study was to compare Ambu® AuraGain™ with LMA® ProSeal™ in patients undergoing laparoscopic surgery. The primary objective was to compare the SADs in terms of OLP. Secondary objectives were comparison of Ambu® AuraGain™ with LMA ProSeal™ in terms of pharyngeal mucosal pressure, ease, number of attempts, time taken for insertion, and haemodynamic response to insertion of the SAD and ease of passage of gastric tube.

Material and Methods

This randomised clinical trial was conducted, from December 2017 to September 2019, at Shri Dharmasthala Manjunatheshwara College of Medical Sciences and Hospital, Dharwad, India in the main OT Complex. After approval from the Institutional Ethical Committee (SDMIEC: 0356: 2017), the trial was registered at Clinical Trial Registry of India (CTRI/2018/03/012836).

Inclusion criteria: Eighty patients of ASA physical status I and II, in the age group of 18-65 years, undergoing laparoscopic surgery were included in the study with a written informed consent.

Exclusion criteria: Patient refusal, inadequate fasting, Gastro Esophageal Reflux Disease (GERD) and restricted mouth opening.

Sample size calculation: Primary outcome of this study was OLP. The mean OLP was considered to be 27.17 cmH2O in the group PLMA, and 28.77 cmH2O in group AAU (7). At an α level of 0.05 and power of 80%, the calculated sample size was 38 patients in each group. A total of 80 patients were recruited, with 40 patients in each group. The flowchart is presented in (Table/Fig 1).

Study Procedure

After a thorough pre-anaesthetic evaluation a day before the scheduled date of surgery, all patients were advised to follow the standard ASA fasting guidelines and were administered with oral ranitidine 150 mg and oral alprazolam 0.5 mg the night before and on the morning of surgery. In the Preoperative Room, Baseline Vital Parameters Heart Rate (HR), Non Invasive Blood Pressure (NIBP) and Oxygen Saturation (SpO2) were recorded. Using the sealed envelope method, the patients were randomly allocated into two groups, group PLMA-LMA® ProSeal™ group and group AAU- Ambu® AuraGain™ group and these envelopes were opened just before shifting the patient to the Operation Theater (OT). Size of the SAD was selected based on the body weight of the patient as per the manufacturer’s recommendation (8),(9). After shifting the patient to the OT, standard monitors were attached and HR, NIBP and SpO2 readings recorded. Intravenous (IV) cannula of appropriate size was secured and IV fluid, ringer’s lactate or normal saline, was administered as per the holliday segar formula throughout the intraoperative period (10). After pre oxygenation with 100% oxygen for 3 minutes, IV fentanyl 2 μg/kg of Body Weight (KgBW) was administered. After 2 minutes, anaesthesia was induced with IV propofol 2 mg/KgBW. After check ventilation, muscle relaxant vecuronium 0.1 mg/KgBW was administered IV. Before inserting the SAD, the cuff of the SAD (LMA® ProSeal™ or Ambu® AuraGain™) was inflated with the maximum permissible air recommended by the manufacturer (8),(9) and the cuff pressure was noted as Pex vivo with a cuff pressure manometer. The SAD was fully deflated and lubricated with a water soluble gel. Patients were ventilated for three minutes with face mask, after which the device was inserted by an experienced anaesthesiologist (experience of more than 250 SAD insertions in clinical practice). The patient was placed in “sniffing” position and in group PLMA: LMA® ProSeal™ of appropriate size was introduced by introducer tool technique (8) and in group AAU, Ambu® AuraGain™ laryngeal mask airway of appropriate size was inserted. After insertion, the device was inflated with maximum permissible volume of air and connected to the ventilator circuit and appearance of end tidal capnogram, absence of leak, adequate chest rise and adequate tidal volume delivery confirmed a successful device insertion. The in vivo cuff pressure Pin vivo was noted and the pharyngeal mucosal pressure was calculated as P=Pin vivo-Pex vivo. Ventilation parameters were volume controlled ventilation with set tidal volume 8 to 10 ml/KgBW with a Positive End Expiratory Pressure (PEEP) of 5 cmH2O, respiratory rate and Inspiration: Expiration ratio (I:E ratio) were adjusted from time to time to maintain an end tidal carbon dioxide of 35 to 45 mmHg.

Anaesthesia was maintained using isoflurane with oxygen and nitrous oxide at FiO2 of 0.4 and a total flow of 1 L/min and minimum alveolar concentration of 1.2. The following parameters were recorded: number of insertion attempts; time taken for insertion from the time the SAD was held till the appearance of capnogram; ease of insertion of SAD: assessed using a scale of 1-4, 1=no resistance, 2=moderate resistance, 3=high resistance, 4=inability to place (11). Haemodynamic parameters: heart rate and blood pressure were recorded every minute for 10 minutes after insertion of the SAD. After confirmation of adequacy of ventilation, peak airway pressures and Pin vivo were noted. If there was no leak and ventilation was adequate, the cuff pressure was set to 60 cmH2O and OLP was noted by closing the expiratory valve of the breathing circuit at a gas flow of 3 L/min, until the seal pressure or a maximum pressure of 40 cmH2O was reached. Peak airway pressures, Pin vivo, and OLP were noted immediately after creation of pneumoperitoneum and at every 30 minute interval up to 2 hours. A lubricated oro gastric tube of appropriate size was introduced via the drain tube of the device. Ease of insertion of gastric tube through the gastric channel was noted on a 3 point scale: 1-3, 1=passed easily, 2=passed with difficulty, 3=impossible to pass (11). In case of failure of insertion of the SAD after 3 attempts or presence of an audible leak with inadequate ventilation, patients were intubated and recorded as failed insertion. All the above parameters were recorded by an independent observer. All the measurements were performed safely, without any complications.

Statistical Analysis

IBM Statistical Packages for Social Sciences (SPSS) Version 22 for windows was used for analysing the data. Categorical data was represented as frequency and percentage whereas, Chi Square test was applied to know the association between the variables. Mean and standard deviation values were calculated for continuous variables. Comparison of mean values between the groups were done using student’s unpaired t-test. The p-value<0.05 was considered statistically significant.

Results

The two groups were comparable in terms of demographic characteristics except for a statistically significant difference in the weight distribution among the two groups (Table/Fig 2).

The two groups were comparable in terms of distribution of type of surgeries (Table/Fig 3). Unpaired t-test was used for the duration of surgery (Mean±S.D of group PLMA 67.75±44.49 min and of group AAU 74.13±31.36 min, p-value=0.460).

The two groups did not differ significantly in terms of size of the SAD used, number of attempts for insertion and the time for insertion. However, PLMA was found to be easier to insert in the first attempt compared to AAU (Table/Fig 4). In 4 cases each in both the groups, there was failure to insert the LMA in the third attempt and endotracheal intubation was done.

In group PLMA, PLMA allowed the passage of 16 Fr gastric drain tube in both sizes 3 and 4. In group AAU, size 4 AAU allowed the passage of 16 Fr gastric drain tube and size 3 allowed 14 Fr gastric drain tube. On comparison of the groups, Chi Square test demonstrated a significant difference (p-value=0.0001). In both the groups were comparable in terms of ease of passage of orogastric drain (Table/Fig 4).

The two groups were comparable in terms of heart rate response and systolic blood pressures in the first 10 minutes after SAD insertion (Table/Fig 5),(Table/Fig 6). Unpaired t-test showed statistically significant Diastolic Blood Pressure (DBP) fluctuations in group AAU compared to group PLMA at 4, 5, 8 and 9 minute after SAD insertion but none of the values were more than baseline DBP (Table/Fig 7).

Unpaired t-test was used for the mean ex vivo pressure in group PLMA was 49.35±29.10 cmH2O and in group AAU was 45.95±26.78 cmH2O (p-value=0.588). Mean peak airway pressures were significantly lower in group AAU than group PLMA immediately after SAD insertion and after creation of pneumoperitoneum, but not later on during the surgery. Mean Pin vivo and mucosal pressures were significantly lower in group AAU than group PLMA immediately, 30 and 60 minutes after creation of pneumoperitoneum, but not later on. The two groups were comparable in terms of OLP at all measured time points (Table/Fig 8).

Discussion

Oro pharyngeal leak pressure: Due to high airway pressures created by pneumoperitoneum in laparoscopic surgery, suboptimal and failed ventilation can be encountered with the use of SADs. But, second generation SADs allow higher airway pressures due to their effective seal (7). OLP test is commonly performed to quantify the seal of airway when SAD is used (12).

In the current study, it was observed that the OLP of group AAU was comparable to group PLMA at all measured time points (Table/Fig 8). A study conducted by Singh K et al., found no significant difference in the OLP between AAU and PLMA (OLP of PLMA was 7.17±16.91 cmH2O and that of AAU was 28.77±4.82 cmH2O immediately after insertion of SAD) which was comparable to the results of this study. Unlike the current study, OLP was measured only once immediately after insertion of the SAD (7).

A study conducted by Shariffuddin II et al., compared OLP of AAU and LMA® Supreme™ Second Seal™ (OLP of AAU 24.1±7.4 cmH2O versus OLP of LMA® Supreme™ Second Seal™ 23.6±6.2 cmH22O) and found no significant difference between them, similar to the current study (13). Here, the study was conducted on spontaneously breathing patients and on all type of surgeries. LMA® Supreme™ Second Seal™ is a single use second generation SAD with features of LMA® Proseal™ incorporated (14).

In a study by Lopez AM et al., in patients undergoing gynaecological laparoscopic surgery, AAU achieved higher OLP than LMA® Supreme™ Second Seal™ throughout the procedure (OLP of AAU 34±5 +++cmH2O versus OLP of LMA® Supreme™ Second Seal™ 29±5 cmH2O), in contrast to the results in the current study (15). In a study conducted by Joshi R et al., the mean OLP of AAU was significantly higher than PLMA (OLP of AAU 23.3±4.6 cmH2O versus OLP of PLMA 20.6±4.8 cmH2O), in contrast to the present study (16). However, this study was conducted on paediatric age group, and not during laparoscopic surgery.

Pharyngeal mucosal pressure: The pharyngeal mucosal pressures, resulting from the SAD cuff, depend on the relative dimensions of the pharynx and the SAD, the degree of accommodation by the pharynx and the inflation pressure required to extend the cuff sufficiently for its function as an airway. The morbidity resulting from this transmitted mucosal pressure is undetermined. It may be an important consideration when prolonged or repeated SAD usage is anticipated. In this case, the intracuff pressure can be monitored, adjusted from time to time and maintained at a value less than the pharyngeal mucosal capillary perfusion pressure and prevent mucosal ischaemia (17). While using SAD, if transmitted pharyngeal mucosal pressure exceeds capillary perfusion pressure, there is a possibility of mucosal ischemia (18). There are a few studies comparing the pharyngeal mucosal pressure exerted by these two SADs under discussion. In this study, group AAU had lower pharyngeal mucosal pressure compared to PLMA group immediately, at 30 and 60 minutes after creation of pneumoperitoneum. But the mean pharyngeal mucosal pressures of the two groups were comparable immediately after insertion of SAD, at 60 and 120 minutes (Table/Fig 8).

Similar results were seen in a study conducted by Singh K et al (7) (pharyngeal mucosal pressure of AAU size 3 was 33.00±18.22 cmH2O and that of PLMA size 3 was 64.00±14.42 cmH2O and pharyngeal mucosal pressure of AAU size 4 was 45.29±27.30 cmH2O and that of PLMA size 4 was 67.68±15.68 cmH2O). Calculated pharyngeal mucosal pressure was lower in group AAU compared to group PLMA. Pharyngeal mucosal pressure was measured in a similar method as in the current study. However, it was measured only once, after insertion of SAD before the pneumoperitoneum.

Number of attempts and time taken for SAD insertion: The current study found no difference between group AAU and group PLMA in terms of number of attempts taken for insertion of the SAD, with insertion being successful in the first attempt in most cases (Table/Fig 4).

The studies conducted by Singh K et al (7) (18/30 cases in first attempt in group AAU versus 24/30 cases in first attempt in group PLMA) and Joshi R et al., (16) (45/47 cases in first attempt in group AAU versus 45/47 cases in group PLMA in the first attempt) also found similar successful insertion rates at first attempt.

In the study conducted by Singh K et al (7), group AAU took a longer time for insertion of SAD compared to the group PLMA (13.57±94 sec in AAU versus 11.60±2.22 sec in PLMA). The authors have attributed rigid Polyvinyl Chloride (PVC) preformed structure of AAU as the cause for prolonged time taken for insertion in comparison to flexible silicone structure of PLMA.

In contrast, time taken for insertion of AAU was significantly shorter in a study conducted by Joshi R et al., (16) (12 sec in AAU versus 20 sec in PLMA) in the paediatric age group. Due to preformed anatomical curve of the SAD, shorter time was taken for insertion of AAU.

The current study showed no difference between the groups in terms of time taken for insertion of SAD (Table/Fig 4).

Ease of Insertion: In this study, it was found that the insertion of PLMA was easier than AAU in the first attempt (Table/Fig 4). In contrast to this, studies conducted by Singh K et al., (7) and Joshi R et al., (16) found no significant difference between the group AAU and group PLMA in terms of ease of insertion.

There was no significant difference between the two groups in terms of haemodynamic response to insertion of SAD.

Passage of gastric tube: PLMA was considered superior over AAU in terms of passage of wider bore gastric tube (Table/Fig 4), in contrast to the results obtained in other studies (7),(16), wherein, AAU allowed the passage of a larger bore gastric tube. However, there was no significant difference noted between the groups in terms of ease of insertion of gastric tube.

Peak airway pressures: It was noted that the mean peak airway pressures in group AAU were lower than group PLMA immediately after insertion of SAD and creation of pneumoperitoneum (Table/Fig 8). Further studies are required to evaluate the differences in peak airway pressures between these SADs.

Limitation(s)

In the present study, an indirect method was employed to measure pharyngeal mucosal pressure producing a derived value. Mucosal pressure in the pharynx can also be measured directly with a microchip sensor which may be more accurate. Postoperative complications such as sore throat, hoarseness, discomfort were not assessed. The placement of SADs was confirmed clinically (visible chest rise and capnography), and not with fibreoptic visualisation of laryngeal aperture. This study included patients undergoing all types of laparoscopic surgeries, position during the procedures was not uniform.

Conclusion

The current study suggests that Ambu® AuraGain™ LMA has oropharyngeal leak pressures similar to LMA® ProSeal™ with a lesser pharyngeal mucosal pressure and lower peak airway pressures. Hence, it can be concluded that Ambu® AuraGain™ could be a useful alternative to LMA® ProSeal™ in patients undergoing laparoscopic surgeries.

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DOI and Others

DOI: 10.7860/JCDR/2022/56407.16481

Date of Submission: Mar 17, 2022
Date of Peer Review: Apr 15, 2022
Date of Acceptance: May 17, 2022
Date of Publishing: Jun 01, 2022

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. NA

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Mar 25, 2022
• Manual Googling: May 11, 2022
• iThenticate Software: May 16, 2022 (16%)

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