| CTRI Number |
CTRI/2023/07/055279 [Registered on: 17/07/2023] Trial Registered Prospectively |
| Last Modified On: |
15/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ultrasound Guided Lung Recruitment Maneuvers] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of lung recruitment maneuvers on post operative atelectasis |
|
Scientific Title of Study
|
To study the efficacy of ultrasound guided lung recruitment maneuvers on atelectasis in patients undergoing laproscopic cholecystectomy : a randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surinder Singh |
| Designation |
Professor & Head Of Department |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department Of Anaesthesiology
Ridge Sanjauli Road Lakkar Bazar
Shimla Himachal Pradesh 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418077565 |
| Fax |
|
| Email |
ss.igmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder Singh |
| Designation |
Professor & Head Of Department |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department Of Anaesthesiology
Ridge Sanjauli Road Lakkar Bazar
Shimla Himachal Pradesh 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418077565 |
| Fax |
|
| Email |
ss.igmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhulika Lakra |
| Designation |
Post Graduate Student |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department Of Anaesthesiology
Ridge Sanjauli Road Lakkar Bazar
Shimla Himachal Pradesh 171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9479245919 |
| Fax |
|
| Email |
lakramadhulika.592shine@gmail.com |
|
|
Source of Monetary or Material Support
|
| Himachal Pradesh Government |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Medical College Shimla |
| Address |
Indira Gandhi Medical College
Ridge Sanjauli Road Lakkar Bazar
Shimla Himachal Pradesh 171001 |
| Type of Sponsor |
Government medical college |
|
|
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 Surinder Singh |
Indira Gandhi Medical College Shimla |
Department Of Anaesthesiology
OT-1,OT-2,Recovery Room-1
Shimla
HIMACHAL PRADESH |
09418077565
ss.igmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Indira Gandhi Medical College Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Lung Ultrasound Score(LUS Score) |
The LUS Score in patients receiving ultrasound guided lung recruitment maneuver for atelectasis in laproscopic cholecystectomies done under general anaesthesia vs control group(not receiving lung recruitment maneuver) will be compared. |
| Intervention |
Ultrasound Guided Lung Recruitment Maneuvers |
Group RM:
Patients randomized to this group will receive ultrasound guided lung recruitment with 5cm H2O PEEP.
Group C:
Patients randomized to this group will receive 5cm H2O PEEP and no ultrasound guided lung recruitment.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients with healthy lungs (negative imaging findings on chest radiograph or CT), aged between 20 and 40 years old, with a body mass index (BMI)<35 kg / m2, American Society of Anesthesiologists (ASA) physical status I-II undergoing elective laparoscopic cholecystectomy surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Patients with cardiac and neuromuscular diseases.
Those undergoing conversion from laparoscopic to open surgery.
Those experiencing critical postoperative complications such as severe subcutaneous emphysema.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the LUS scores (LUS Score)in patients receiving ultrasound guided lung recruitment maneuvre for atelectasis, in laproscopic cholecystectomies done under general anaesthesia vs control group ie, in patients not receiving lung recruitment manuvere. |
5 time intervals in perioperative period of 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the correlation between atelectasis & oxygen saturation & post-operative pulmonary complications(any episode of saturation less than 90% on room air in next 24 hrs)in both the groups. |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/07/2023 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Recently the application of ultrasound in the diagnosis of lung condition has proven to be safe, noninvasive, easy to use, inexpensive and point of care imaging tool with reproducible results.It can be used to diagnose and monitor atelectasis accurately with asensitivity of 80%.The use of protective lung ventilation has been associated with a lower incidence of atelectasis and pulmonary complications.Although PEEP alone can improve intraoperative oxygenation, studies have shown that use of lung recruitment maneuvres(LRM) and PEEP can improve oxygenation and reduce the incidence of pulmonary complications in patients undergoing laproscopic surgeries.Also the LRMs are useful in reopening the atelectatic lung zones.Prevention of lung atelectasis early in intraoperative period has been reported to lessen the incidence of post operative pulmonary complications.However the studies have included wide and varying types of patient population and diverse surgical procedures, the result of which cannot be applied universally.Therefore it is proposed to selectively evaluate occurence of lung atelectasis in patients undergoing laproscopic cholecystectomy under general annaesthesia and to evaluate the efficacy of lung recruitment manuevers in preventing atelectasis in these patients. |