| CTRI Number |
CTRI/2024/12/078063 [Registered on: 13/12/2024] Trial Registered Prospectively |
| Last Modified On: |
12/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the effect of pressure on the lungs during surgery on breathing problems after surgery in patients undergoing abdominal cancer surgeries |
|
Scientific Title of Study
|
Effects of Intraoperative Driving pressure on postoperative pulmonary complications in patients undergoing Minimally Invasive Colorectal Oncological surgeries: A Prospective Observational Study |
| Trial Acronym |
InDrive Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malini Joshi |
| Designation |
Professor , Department of Anesthesia,Critical Care and Pain,ACTREC,Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malini Joshi |
| Designation |
Professor , Department of Anesthesia,Critical Care and Pain,ACTREC,Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Thanma Vidyababu |
| Designation |
Junior Resident, Department of Anesthesia, Critical Care and Pain, Tata Memorial Centre |
| Affiliation |
ACTREC, Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
8296870596 |
| Fax |
|
| Email |
thanmavidyababu@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai, Pin-410210, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
ACTREC, Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai |
| 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 Malini Joshi |
ACTREC, Tata Memorial Centre |
Dept of Anaesthesiology, Critical Care and Pain, 7th floor, Rajarao Shodhika Building, ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
Mumbai
MAHARASHTRA |
9987226657
jmalini2007@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACTREC,Institutional Ethical Committee 3 |
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
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 18 years planned for minimally invasive colorectal surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Emergency surgeries and Redo surgeries
2. Day care surgeries
3. Surgeries lasting for less than 2 hours
4. Patients with respiratory infection in the previous month
5. Patients with preexisting lung disease, poor ECOG and poor effort tolerance
6. Refusal to participate in the trial
7. Pregnant patients
8. Laparoscopic/Robotic surgery converted to open surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of intraoperative driving pressures on incidence of postoperative
pulmonary complications with simplified clinical pulmonary infection score in patients
undergoing minimally invasive colorectal surgeries. |
Data will be collected during the surgery and in the postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess the effect of mechanical power 6 on the incidence of postoperative pulmonary complications in the patients undergoing minimally invasive colorectal surgeries
2.To assess the patient outcomes |
Data will be collected during the surgery and in the postoperative period |
|
|
Target Sample Size
|
Total Sample Size="103"
Sample Size from India="103"
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
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2024 |
| 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 Applicable |
| 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
|
The purpose of this study is to investigate the relationship between intraoperative driving pressure and
postoperative pulmonary complications. It is a prospective observational study to be conducted over a period of 1 year in operating room of ACTREC, Tata Memorial Centre. This study will include patients of age
more than 18 years undergoing minimally invasive colorectal cancer surgeries
for a duration of more than 2 hours. On admission for surgery we will assess
the fitness of the patient and obtain a written informed consent. Patients
fulfilling the inclusion criteria will be observed intraoperatively. We will
record all the vital intraoperative parameters and the ventilator parameters
including the driving pressure and follow up the patients in the postoperative
period for 30 days or until discharge for occurrence of any pulmonary
complications. |