| CTRI Number |
CTRI/2024/03/064572 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on lung functions during general anaesthesia. |
|
Scientific Title of Study
|
Comparing effects of different levels of Positive end-expiratory pressure on aeration score in laparoscopic surgeries using lung ultrasound - Randomized Controlled 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 VISHALI R |
| Designation |
Postgraduate ( MD Anaesthesiology ) |
| Affiliation |
SRM Medical College and hospital AND RESEARCH CENTER |
| Address |
Room no 209
B block
2nd floor department of anaesthesia
SRM Medical College and hospital
kattankulathur
kancheepuram
TAMILNADU
603203
INDIA
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8754585173 |
| Fax |
0 |
| Email |
vishalishanker1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PUSHPARANI |
| Designation |
PROFESSOR, DEPT OF Anaesthesiology ) |
| Affiliation |
SRM Medical College and hospital AND RESEARCH CENTER |
| Address |
Room no 209
B block
2nd floor department of anaesthesia
SRM Medical College and hospital
kattankulathur
kancheepuram
TAMILNADU
603203
INDIA
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003242601 |
| Fax |
0 |
| Email |
pushpa82_dr@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PUSHPARANI |
| Designation |
PROFESSOR, DEPT OF Anaesthesiology ) |
| Affiliation |
SRM Medical College and hospital AND RESEARCH CENTER |
| Address |
Room no 209
B block
2nd floor department of anaesthesia
SRM Medical College and hospital
kattankulathur
kancheepuram
TAMILNADU
603203
INDIA
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003242601 |
| Fax |
0 |
| Email |
pushpa82_dr@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college and hospital and Research Institution |
|
|
Primary Sponsor
|
| Name |
SRM |
| Address |
ROOM NO:209, B- BLOCK, 2nd Floor, Department of Anesthesiology,
SRM medical college and research center, kattankulathur |
| 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 VISHALI R |
SRM Institute of Science and Technology |
B-206, B-BLOCK, 2nd
floor, Department of
anesthesiology, SRM
Medical college and
Research Institute,
Kattankulathur
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
8754585173
0
vishalishanker1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Students SRM Medical College Hospital. |
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 |
| Intervention |
Positive end-expiratory pressure PEEP 10 |
To study the aeration score postoperatively using lung ultrasound in patients undergoing laparoscopic surgeries with PEEP 10 for 1 hour intraoperatively under general anaesthesia. |
| Comparator Agent |
Positive end-expiratory pressure PEEP 5 |
To study the aeration score postoperatively using lung ultrasound in patients undergoing laparoscopic surgeries with PEEP 5 for 1 hour intraoperatively under general anaesthesia. |
| Intervention |
Positive end-expiratory pressure PEEP 7 |
To study the aeration score postoperatively using lung ultrasound in patients undergoing laparoscopic surgeries with PEEP 7 for 1 hour intraoperatively under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
PATIENTS UNDERGOING LAPAROSCOPIC SURGERIES UPTO 2 HOURS. |
|
| ExclusionCriteria |
| Details |
1.patients with cardiopulmonary disorders
2.pregnancy
3.smokers |
|
|
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 |
| To study the aeration score[atelectatic changes] pre op &post op |
To study the aeration score[atelectatic changes] pre op &post op at interval of 10, 30 & 60 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to monitor hemodynamic changes at different PEEP LEVELS 5,7,10 |
to monitor hemodynamic changes INTAOPERATIVELY at different PEEP LEVELS 5,7,10 EVERY 5 MINUTES |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/04/2024 |
| 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
|
IN THIS CLINICAL TRIAL, 120 PATIENTS AGED BETWEEN 18 TO 65 YEARS , ASA I & II WITH BMI< 30 UNDERGOING LAPAROSCOPIC SURGERIES WERE RANDOMLY ASSINGED TO THREE GROUPS TO ASSESS AERATION SCORE.
PEEP 5; 40 CASES, PEEP 7; 40 CASES, PEEP 10; 40 CASES. ( INTRAOPERATIVELY ) AERATION SCORE USING LUNG ULTRASOUND SCORE SYSTEM WILL BE COMPARED BEFORE GENERAL ANESTHESIA INDUCTION AND IMMEDIATELY AFTER ARRIVAL TO RECOVERY ROOM AT INTERVALS OF 10, 30 AND 60 MINUTES.
|