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CTRI Number  CTRI/2017/11/010452 [Registered on: 10/11/2017] Trial Registered Retrospectively
Last Modified On: 11/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two devices which help the patient breathe under general anaesthesia - the endotracheal tube and the supreme laryngeal mask airway, for patients undergoing gall bladder removal surgery laparoscopically. 
Scientific Title of Study   The comparison between supreme laryngeal mask airway and endotracheal tube with respect to adequacy of ventilation in patients undergoing laparoscopic cholecystectomy under general anaesthesia. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepak Bhushan 
Designation  D.N.B. Student 
Affiliation  P.D. Hinduja National Hospital and Medical Research Centre 
Address  202, Siddhesh Jyoti building, 20th Floor, F-wing, Balaram Street, Grant road east

Mumbai
MAHARASHTRA
400007
India 
Phone  9821859729  
Fax    
Email  lion.deepak@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sunita Nandkumar 
Designation  M.D. 
Affiliation  P.D. Hinduja National Hospital and Medical Research Centre 
Address  P.D.Hinduja National Hospital and Medical Research Center Veer Savarkar Marg Mahim

Mumbai
MAHARASHTRA
400016
India 
Phone  9820021613  
Fax    
Email  nansun2006@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Deepak Bhushan 
Designation  D.N.B. Student 
Affiliation  P.D. Hinduja National Hospital and Medical Research Centre 
Address  202, Siddhesh Jyoti building, 20th Floor, F-wing, Balaram Street, Grant road east

Mumbai
MAHARASHTRA
400007
India 
Phone  9821859729  
Fax    
Email  lion.deepak@gmail.com  
 
Source of Monetary or Material Support  
P.D. Hinduja National Hospital and Medical Research Centre Veer Sawarkar Marg, Asavari, Mahim, Mumbai, Maharashtra 400016 
 
Primary Sponsor  
Name  PD Hinduja National Hospital and Medical Research Centre 
Address  Veer Sawarkar Marg, Asavari, Mahim, Mumbai, Maharashtra-400016 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Deepak Bhushan  P.D. Hinduja National Hospital and Medical Research Centre  Department of Anaesthesiology, Operation Theatre, 3rd Floor, Main building, Veer Sawarkar Marg, Asavari, Mahim, Mumbai, Maharashtra 400016
Mumbai
MAHARASHTRA 
9821859729

lion.deepak@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with gall stones, for removal of the gall bladder, by laparoscopic surgery.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Endotracheal Tube  Considered the gold standard in securing and maintaining airway during general anaesthesia.  
Intervention  Supreme Laryngeal Mask Airway  This is a second generation Supraglottic Airway device, for maintaining airway during general anaesthesia. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Consecutive 132 American Society of Anesthesiologists
(ASA) status I and II adults of either sex, aged 20-65 years and body weight
40-80 kg, scheduled for elective laparoscopic cholecystectomy, under general
anaesthesia, who had given consent to participate was recruited. 
 
ExclusionCriteria 
Details  Patients with anticipated difficult airway,
Obesity (body mass index >30 kg/m2),
Oropharyngeal pathology,
Cardiopulmonary disease,
Cervical spine fracture or instability,
Increased risk of aspiration 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Adequacy of ventilation
i) Quality of glottic airway seal – Difference between Inspired tidal volume and
Expired tidal volume
ii) Oxygen saturation
iii) EtCO2
iv) Peak airway pressures 
From insertion of airway device to end of anaesthesia. 
 
Secondary Outcome  
Outcome  TimePoints 
2. Ease of Insertion
Time required for achieving effective airway and the number of attempts for securing
airway.
3. Haemodynamic responses (heart rate, systolic, diastolic and mean arterial blood
pressure) was recorded before induction; at the time of insertion; 1 and 5 min after
insertion of device, on pneumoperitoneum inflation and deflation, and on extubation.
4. Complications
Incidences of gastric distension, aspiration and post-operative sore throat. 
From induction of anaesthesia to 24 hours after surgery. 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="132" 
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="132" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/03/2015 
Date of Study Completion (India) 04/06/2016 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Asian Journal of Anesthesiology: 1-8, 2022 DOI:10.6859/aja.202202/PP.0001 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Hypothesis- The ventilation of patients is adequate with both Supreme Laryngeal Mask Airway (LMAS) and Endotracheal Tube (ETT) undergoing laparoscopic cholecystectomy under general anesthesia. My question is whether LMAS is better than or similar to ETT in the ventilation of the patient.

Rationale- Laparoscopic cholecystectomy is done under general anesthesia. Under general anesthesia the patient cannot breathe on his own, so we need to put in an airway device to mechanically ventilate his lungs.

Till date, the cuffed endotracheal tube was considered as the gold standard for providing a safe seal in the larynx, especially for laparoscopic procedures under general anesthesia. The disadvantages of tracheal intubation, which involves rigid laryngoscopy, are in terms of concomitant haemodynamic responses and damage to the oropharyngeal structures at insertion. Postoperative sore throat is also a serious concern. This precludes the global utility of the tracheal tube and requires a better alternative. Over a period of time, new airway devices have been added to the anaesthesiologist’s armamentarium.

Supreme laryngeal mask airway (LMAS) is a supraglottic device which has an advanced cuff to provide a better seal around the laryngeal opening and permits peak airway pressure more than 30 cm water without leak. It has a drain tube parallel to the ventilation tube which permits drainage of passively regurgitated gastric fluid away from the airway and serves as a passage for gastric tube. The LMAS is single use, latex free and is made of medical grade PVC. The firm, elliptical and anatomically shaped airway tube facilitates easy insertion, without placing fingers in the patient’s mouth or placing an introducer tool for insertion. 

This study is therefore undertaken to see if LMAS provides better or similar ventilation than ETT in healthy adult patients undergoing laparoscopic cholecystectomy under general anesthesia.

 
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