| 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
|
|
|
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
|
|
|
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. |