| CTRI Number |
CTRI/2023/11/059682 [Registered on: 08/11/2023] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
positive end pressure ventilation effects on lungs during abdominal surgery |
|
Scientific Title of Study
|
EFFECT OF POSITVE END EXPIRATORY PRESSURE ON POST OPERATIVE ATELECTASIS FOR OPEN ABDOMINAL SURGERY : A PROSPECTIVE RANDOMIZED CONTROLLED STUDY |
| Trial Acronym |
EPEEP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SYED HAZARATH NABI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY SRI DEVARAJ URS MEDICAL COLLEGE TAMAKA
KOLAR
DEPARTMENT OF ANAESTHESIOLOGY
SRI DEVARAJ URS MEDICAL COLLEGE TAMAKA
KOLAR
Kolar
KARNATAKA
563101
India |
| Phone |
8553652356 |
| Fax |
|
| Email |
hazarath.syed@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SURESH KUMAR N |
| Designation |
PROFESSOR |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SRI DEVARAJ URS MEDICAL COLLEGE TAMKA KOLAR
DEPARTMENT OF ANAESTHESIOLOGY
SRI DEVARAJ URS MEDICAL COLLEGE TAMKA KOLAR
Kolar
KARNATAKA
563101
India |
| Phone |
9008222550 |
| Fax |
|
| Email |
drskumar6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SYED HAZARATH NABI |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SRI DEVARAJ URS MEDICAL COLLEGE |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SRI DEVARAJ URS MEDICAL COLLEGE TAMKA KOLAR
DEPARTMENT OF ANAESTHESIOLOGY
SRI DEVARAJ URS MEDICAL COLLEGE TAMKA KOLAR
Kolar
KARNATAKA
563101
India |
| Phone |
8553652356 |
| Fax |
|
| Email |
hazarath.syed@outlook.com |
|
|
Source of Monetary or Material Support
|
| SRI DEVARAJ URS MEDICAL COLLEGE,TAMAKA, KOLAR 563103. |
|
|
Primary Sponsor
|
| Name |
DR SYED HAZARATH NABI |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
SRI DEVARAJ URS MEDICAL COLLEGE TAMKA KOLAR 563101 |
| Type of Sponsor |
Other [SELF - DR. SYED HAZARATH NABI] |
|
|
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 SYED HAZARATH NABI |
R.L.JALAPPA HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF ANAESTHESIOLOGY
SRI DEVARAJ URS MEDICAL COLLEGE
TAMAKA
Kolar
KARNATAKA |
8553652356
hazarath.syed@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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) |
PEEP IS KEPT AT 4 CM OF H20 OR 8 CM OF H20. |
| Comparator Agent |
POST OPERATIVE ATELECTASIS |
BY USING INTERVENTION, DEVELOPMENT OF POST OPERATIVE ATELECTASIS IN PATIENTS UNDERGOING OPEN ABDOMINAL SURGERIES UNDER GENERAL ANAESTHESIA ARE ASSESSED USING THE ULTRASOUND IN THE PRE OP AND 30 MINUTES AFTER THE SURGERY IN BOTH LUNGS , WHERE EACH LUNG IS DIVIDED INTO 6 QUADRENTS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT OLDER THAN 18 YRS OF AGE AND UNDERGOING OPEN ABDOMINAL SURGERY OF EXPECTED DURATION MORE THAN 2 HOURS.
PATIENTS WITH AMERICAN SOCIETY OF ANAESTHESIOLOGISTS(ASA) PHYSICAL STATUS 1 - 3 AND BODY MASS INDEX LESS THAN 35Kg/meter2. |
|
| ExclusionCriteria |
| Details |
LAPAROSCOPIC SURGERIES
PREVIOUS LUNG OR THORACIC SURGERIES
PERSISTANT HAEMODYNAMIC INSTABILITY
HISTORY OF COPD
SYSTEMIC CORTICOSTERIOD THERAPY
RECENT IMMUNOSUPPRESSIVE MEDICATION AND RADIOTHERAPY
SEVERE CARDIAC DISEASE AS NYHA CLASS 3 -4
PREGNANCY
ACUTE LUNG INJURY OR ARDS |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE EFFECT OF POSITIVE END EXPIRATORY PRESSURE UNDER GENERAL ANAESTHESIA FOR OPEN ABDOMINAL SURGERIES MORE THAN 2 HOURS OF DURATION ON POST OPERATIVE ATELECTASIS |
LUNG ULTRASOUND IS PERFORMED IN PREOPERATIVE ROOM BEFORE SURGERY AND 30 MINUTES AFTER THE SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
TO DETERMINE THE DEGREE AND INCIDENCE OF HYPOTENSION DURING THE INTRAOPERATIVE MECHANICAL VENTILATION
TO DETERMINE THE INCIDENCE OF INCREASED AIRWAY PRESSURES AND BAROTRAUMA DURING INTRAOPERATIVE MECHANICAL VENTILATION |
ASSESSMENT WILL BE DONE INITIALLY FOR EVERY 5 MINUTES FOR 30 MINUTES INTIALLY FOLLOWED BY EVERY 15 MINUTES TILL THE END OF SURGERY. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2023 |
| Date of Study Completion (India) |
30/04/2024 |
| Date of First Enrollment (Global) |
10/11/2023 |
| Date of Study Completion (Global) |
30/04/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Other (Terminated) |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
PURPOSE OF THE STUDY:-
Patients undergoing mechanical ventilation during the surgery are prone to lung atelectasis postoperatively. application of appropriate levels of PEEP and using lung protective ventilation strategies not only reduces post operative atelectasis but also decreases post operative pulmonary complications like barotrauma, ateletrauma and acute lung injury. So, we intended to study the effects of different levels of PEEP application during intraoperative ventilation on the incidence of postoperative atelectasis.
in our study, we found that patients intervened with PEEP 4 or PEEP 8 did not have any postoperative atelectasis. but there was a significant hypotension, increased peak pressures, plateau pressures in the group B i.e., PEEP 8 than Group A PEEP 4. |