| CTRI Number |
CTRI/2021/02/031436 [Registered on: 22/02/2021] Trial Registered Prospectively |
| Last Modified On: |
19/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to study the effect of oxygen supplementation to reduce the surgical wound infections in abdominal surgeries. |
|
Scientific Title of Study
|
to study the effect of perioperative oxygen supplementation to reduce the incidence of surgical site infections in patients undergoing elective major abdominal surgeries - a randomised control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NILADRI MOHAN RAYPATTANAIK |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
Department Of general Surgery,
5th Level, B - Block,
Neheru Hospital,
PGIMER
Department Of general Surgery,
5th Level, B - Block,
Neheru Hospital,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7008171358 |
| Fax |
|
| Email |
niladrimohan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF LILESWAR KAMAN |
| Designation |
PROFESSOR |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF GENERAL SURGERY,
5TH LEVEL, B - BLOCK,
NEHERU HOSPITAL,
PGIMER
DEPARTMENT OF GENERAL SURGERY,
5TH LEVEL, B - BLOCK,
NEHERU HOSPITAL,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7087009644 |
| Fax |
|
| Email |
kamanlil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
NILADRI MOHAN RAYPATTANAIK |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
| Address |
DEPARTMENT OF GENERAL SURGERY,
5TH LEVEL, B - BLOCK,
NEHERU HOSPITAL,
PGIMER
DEPARTMENT OF GENERAL SURGERY,
5TH LEVEL, B - BLOCK,
NEHERU HOSPITAL,
PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7008171358 |
| Fax |
|
| Email |
niladrimohan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
POST GRADUATE INSTITUTE OF MEDICAL COLLEGE AND HOSPITAL |
| Address |
PGIMER
CHANDIGARH
INDIA
PIN-160012 |
| 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 |
| NILADRI MOHAN |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
DEPARTMENT OF GENERAL SURGERY,
5TH LEVEL, B - BLOCK,
NEHERU HOSPITAL,
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
CHANDIGARH-12
Chandigarh
CHANDIGARH |
7008171358
niladrimohan@gmail.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: C185||Malignant neoplasm of splenic flexure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PERIOPERATIVE OXYGEN SUPPLIMENTATION |
After the induction of anaesthesia and endotracheal intubation, each patient will be assigned to one of two groups through the use of a set of sealed envelope method of generated random numbers. The assignments are stratified according to the patient details and were kept in sealed, sequentially numbered envelopes until used. One group of patients (Group-A) will receive 30 percent oxygen and 70 percent nitrous oxide; the second group (Group–B) will receive 80 percent oxygen and 20 percent nitrous oxide. The first group (Group-A) will receive 30% (28-35%) FiO2 in post-operative period for two hours at a flow rate of 8lt/min through venturi mask to achieve desired SpO2 99-100%. The second group (Group-B) will also receive also receive up to 80% (80-100%) FiO2 in post-operative period for two hours at a flow rate of 15lt/min through non rebreather mask. |
| Comparator Agent |
THE REDUCE INCIDENCE OF SURGICAL SITE INFECTIONS. |
Primary Objective: To study the effect of varying perioperative oxygen supplementation to reduce the incidence of surgical site infections in patients undergoing elective major abdominal surgeries.
Secondary Objective: To study other morbidities; upper respiratory tract infection, urinary tract infection, anastomotic integrity, intensive care unit (ICU) stay, length of Hospital Stay (LoHS) and the need for postoperative interventions including surgery and mortality. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients eligible to give valid consent for the study.
2. Patients undergoing all types of elective major abdominal surgeries including upper gastrointestinal, hepato-pancreato-biliary and lower gastrointestinal like colorectal surgeries. |
|
| ExclusionCriteria |
| Details |
1. Immunocompromised patients including poorly controlled diabetes mellitus, patient on long standing steroids.
2. Patient having comorbidities including severe COPD, severe Bronchial Asthma, or any chronic interstitial lung diseases.
3. Patients with any Percutaneous intraabdominal drainage catheter in situ with positive culture report.
4. Patient who receives antibiotic or antiseptic irrigation (IOPL) of the wound or peritoneal cavity during intraoperative period. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO SEE THE REDUCE INCIDENCE OF SURGICAL SITE INFECTIONS IN MAJOR ABDOMINAL SURGERIES. |
TILL 4 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see other morbidities; upper respiratory tract infection, urinary tract infection, anastomotic integrity, intensive care unit (ICU) stay, length of Hospital Stay (LoHS) and the need for postoperative interventions including surgery and mortality. |
TILL 4 WEEKS |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/02/2021 |
| 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="0"
Months="11"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TO STUDY THE EFFECT OF VARYING PERIOPERATIVE OXYGEN
SUPPLEMENTATION TO REDUCE THE INCIDENCE OF SURGICAL SITE
INFECTIONS IN PATIENTS UNDERGOING ELECTIVE MAJOR ABDOMINAL
SURGERIES - A RANDOMIZED CONTROL STUDY
|