| CTRI Number |
CTRI/2022/10/046764 [Registered on: 25/10/2022] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Driving pressure guided positive end expiratory pressure (PEEP) vs fixed PEEP in preventing lung collapse |
|
Scientific Title of Study
|
A comparative study of driving pressure guided
individualized versus fixed positive end expiratory pressure
on incidence of postoperative lung atelectasis in patients
undergoing laparoscopic surgeries in trendelenburg position
: A double blinded random |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudeep Takoor |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, All India Institute of Medical Sciences.
Department of Anaesthesiology, All India Institute of Medical Sciences.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9538104933 |
| Fax |
|
| Email |
sudeeptakoor1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamta |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
c-404, Barsana Enclave, Mobha Bazaar, Tatibandh
Department of Anaesthesiology, All India Institute of Medical Sciences.
Raipur
CHHATTISGARH
492099
India |
| Phone |
9818113061 |
| Fax |
|
| Email |
drmamta12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sudeep Takoor |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
c-404, Barsana Enclave, Mobha Bazaar, Tatibandh
Department of Anaesthesiology, All India Institute of Medical Sciences.
CHHATTISGARH
492099
India |
| Phone |
9538104933 |
| Fax |
|
| Email |
sudeeptakoor1@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
All India Institute of Medical Sciences, Raipur |
| 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 Sudeep Takoor |
All India Institute of Medical Sceinces, Raipur |
Operation Theater, Department of Anaesthesiology, All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH |
9538104933
sudeeptakoor1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Driving pressure guided positive end expiratory intra operatively |
Driving pressure guided PEEP (PLAT-PEEP) will be used to find out the individualized PEEP using the incremental PEEP protocol and the respective PEEP will be set for the rest of the duration of surgery. Lung ultrasound will be done 30 minutes after extubation in the post anaesthesia care uni and the lung ultrasound score will be noted. |
| Comparator Agent |
Fixed positive end expiratory pressure |
In the control group fixed PEEP of 5cmh2o will be given throughout the surgery. Lung ultrasound will be done in both the groups and the lung USG score will be compared in two groups in the post anaesthesia care unit 30 minutes after extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients undergoing laparoscopic urological and gynaecological surgeries.
2) ASA PS 1 & 2 patients |
|
| ExclusionCriteria |
| Details |
1) Patients refusal to participate in the study
2) Previous thoracic surgeries or massive blood loss >40ml/Kg
3) Patients with ARDS / lung injury / COPD / chronic lung disease.
4) Recent history of upper respiratory tract infection/ history of bronchial asthma
5) Significant cardiac, renal or hepatic disease.
BMI <18 or >30 Kg/m2
|
|
|
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 identify whether an individualized PEEP guided by driving pressures can reduce the magnitude of postoperative ( 30 minutes after extubation) lung atelectasis as compared to a fixed PEEP assessed by change in modified lung ultrasound score |
24 hours after extubation of the patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative oxygen requirement |
Post operative period |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "82"
Final Enrollment numbers achieved (India)="82" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2022 |
| Date of Study Completion (India) |
27/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
- The study will be done on patients undergoing laparoscopic urological or gynecological surgeries in trendelenberg position.
- 82 randomized patients will be recruited of which 41 patients will be assigned to study group and 41 patients will be assigned to control group.
- The participants in the test group shall receive driving pressure guided individualized PEEP and the control group participants shall receive fixed PEEP throughout the surgery.
- Driving pressures would be calculated by using the formula (Pplat - PEEP) and the PEEP at which lowest possible driving pressures are observed is fixed throughout the surgery.
- Lung recruitment will be done in both the study groups. Incremental PEEP protocol shall be used in test group.
- The principal investigator is blinded to the study groups and the intervention will be done by an experienced anesthesiologist in the operation theater.
- After the patient is shifted to the post anesthetic care unit lung ultrasound will be done by the principal investigator to look for any B lines and lung consolidation and Lung Ultrasound Sore (LUS) will be determined based on USG findings.
- Other parameters like intra operative arterial blood gas analysis, ventilatory parameters, vitals, details of the surgery will be recorded in the case record form.
- On completion both the groups will be studied and analyzed independently and various parameters mentioned above will be compared.
|