| CTRI Number |
CTRI/2022/10/046760 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
18/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison OF two airway devices used in paients undergoing surgery for gallbladder stone. |
|
Scientific Title of Study
|
A Comparative Study of Respiratory mechanics in Patients undergoing day care laparoscopic cholecystectomy using LMA ProSeal vs LMA Protector. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bimla Sharma |
| Designation |
Senior Consulant |
| Affiliation |
sir gangaram hospital |
| Address |
ROOM NO 10
SSRB 5TH FLOOR
INSTITUTE OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDicine
sir gangaram hospital old rajender nagar new delhi
New Delhi DELHI 110060 India |
| Phone |
9810135366 |
| Fax |
|
| Email |
bimsharma1@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Bimla Sharma |
| Designation |
Senior Consulant |
| Affiliation |
sir gangaram hospital |
| Address |
ROOM NO 10
SSRB 5TH FLOOR
INSTITUTE OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDicine
sir gangaram hospital old rajender nagar new delhi
New Delhi DELHI 110060 India |
| Phone |
9810135366 |
| Fax |
|
| Email |
bimsharma1@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Bimla Sharma |
| Designation |
Senior Consulant |
| Affiliation |
sir gangaram hospital |
| Address |
ROOM NO 10
SSRB 5TH FLOOR
INSTITUTE OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDicine
sir gangaram hospital old rajender nagar new delhi INSTITUTE OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDicine
sir gangaram hospital old rajender nagar new delhi New Delhi DELHI 110060 India |
| Phone |
9810135366 |
| Fax |
|
| Email |
bimsharma1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Rm Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital |
| Address |
Old Rajinder Nagar, Sarhadi Gandhi Marg, New Delhi, Delhi 110060 · |
| 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 |
| Dr Bimla Sharma |
Sir Ganga Ram Hospital, New Delhi |
Operation Theatre 5th Floor, SSRB New Building, Sir Ganga Ram Hospital Marg, New Delhi 110060 Central DELHI |
9810135366
bimsharma1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institional Ethics Committee, SGRH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LMA proseal |
It is a supraglottic airway device made of medical grade silicon. It has built in drainge tube for gastric drainage which helps in prevention of aspiration.
(Duration:30 minutes to 2 hours) |
| Intervention |
LMA protector |
It is a newly developed supraglottic airway device with 2 gastric drainage which helps in preventing aspiration
(Duration:30 minutes to 2 hours) |
| Comparator Agent |
No any |
No any |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status 1 and 2
2. BMI <35 |
|
| ExclusionCriteria |
| Details |
1.BMI >35
2. Patient with upper respiratory tract infection
3. Patient at risk of aspiration
4. Anticipated difficult airway
5. Mouth opening less than 2.5 cm
6. Patient with lung disease
patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of dynamic compliance using LMA® ProSeal™ vs. LMA® Protector™ in patients undergoing lap cholecystectomy. |
1. At insertion of the device
2. At 5 minutes after insertion of the device.
3. At 10 minutes after insertion of the device
4. At the initiation of carboperitoneum
5. At 5 minutes of carboperitoneum
6. At 10 minutes of carboperitoneum
7. At 20 minutes of carboperitoneum
8. At the release of carboperitoneum
9. 5 minutes afterthe release of carboperitoneum
10. 10 minutes after the release of carboperitoneum
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of
Airway resistance
Peak airway pressure
Plateau pressure
SpO2
Fibreoptic evaluation of the position of the airway device.
Intraoperative and postoperative complications
|
1. At insertion of the device
2. At 5 minutes after insertion of the device.
3. At 10 minutes after insertion of the device
4. At the initiation of carboperitoneum
5. At 5 minutes of carboperitoneum
6. At 10 minutes of carboperitoneum
7. At 20 minutes of carboperitoneum
8. At the release of carboperitoneum
9. 5 minutes afterthe release of carboperitoneum
10. 10 minutes after the release of carboperitoneum
|
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Minimally invasive laparoscopic surgery has revolutionized surgical practice and influenced the practice of anaesthesiology. Improvement in surgical and anaesthetic techniques has led to surgeries being performed on an outpatient basis with better pain management,early recovery and short duration of admission.General anaesthesia with controlled ventilation is the technique of choice in laparoscopic surgeries. The record success of laryngeal mask airway in resuscitation, difficult airway management and anaesthesia lead to the introduction of several supraglottic airway devices (SADs) into clinicalpractice.SADsoffer several advantages over endotracheal tubes including ease of insertion, reduced haemodynamic response,decreased airway tolerance and lesser pharyngolaryngealmorbidity.1-5 The introduction of second-generation SADs having gastric drainage tube provide a better oropharyngeal seal and improved protection against regurgitation and pulmonary aspiration. LMA® Protector™ is a recently developed SAD with few published studies on its utility to date. It is made of medical-grade silicone which makes it more flexible and less traumatic than previous LMA devices made up of PVC. It is a single-use second generation SAD designed with a large volume conduit with gastric assess and a fixed curved structure to facilitate insertionand an inflatable airway cuff.6 Additionally, the LMA Protector is available with a pilot balloon or the integrated cuff pilot that provides easier adjustment of the intracuff pressure.7 Since LMA® Protector™ was introduced in 2015 as the most advanced second-generation device, we want to compare this device with LMA® ProSeal™, one of the most frequently used devices in any institution. Until now, only a few studies have compared the clinical efficacy of the LMA® Protector™ with other SADs. In this study, we aim to compare the respiratory mechanics with LMA® ProSeal™ vs.LMA® Protector™ in patients undergoing day care laparoscopic cholecystectomy. |