| CTRI Number |
CTRI/2024/03/063635 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
04/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Mechanical power of ventilation and pulmonary complications after surgery |
|
Scientific Title of Study
|
Association of intraoperative mechanical power of ventilation with occurrence of post-operative respiratory failure in patients undergoing major abdominal onco surgery in a tertiary cancer center in North Kerala |
| 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 Joona P |
| Designation |
Assistant Professor |
| Affiliation |
Malabar cancer center |
| Address |
Department of Oncoanesthesiology, Malabar cancer center, Moozhikkara P.O, Thalassery, Kannur
Kannur
KERALA
670103
India |
| Phone |
9496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Joona P |
| Designation |
Assistant Professor |
| Affiliation |
Malabar cancer center |
| Address |
Department of Oncoanesthesiology, Malabar cancer center, Moozhikkara P.O, Thalassery, Kannur
Kannur
KERALA
670103
India |
| Phone |
9496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Joona P |
| Designation |
Assistant Professor |
| Affiliation |
Malabar cancer center |
| Address |
Department of Oncoanesthesiology, Malabar cancer center, Moozhikkara P.O, Thalassery, Kannur
Kannur
KERALA
670103
India |
| Phone |
9496651604 |
| Fax |
|
| Email |
drjoonap@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Malabar cancer center |
| Address |
Moozhikkara P.O, Kodiyeri, Thalassery, Kannur, Kerala, 670103 |
| 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 Joona P |
Malabar cancer center |
Department of Oncoanesthesiology,Moozhikkara P.O,Kodiyeri, Thalassery, Kannur
Kannur
KERALA |
09496651604
drjoonap@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee malabar cancer center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than 18 years of age and less than 80 years of age and patients undergoing major abdominal onco surgery under general anaesthesia with mechanical ventilation more than three hours
|
|
| ExclusionCriteria |
| Details |
Patients undergoing emergency surgeries
Patients who cannot be followed up for first seven postoperative days
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the association between intraoperative mechanical power of ventilation and postoperative respiratory failure |
after one week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the association between intraoperative mechanical power of ventilation and other postoperative pulmonary complications |
In first seven postoperative days |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
12/03/2024 |
| 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="0"
Months="10"
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
|
To find out the association between intraoperative mechanical power of ventilation and postoperative respiratory failure and pulmonary complications in first seven postoperative days. If there is significant association, we can be more vigilant for patients with high intraoperative mechanical power during extubation in the postoperative period . |