| CTRI Number |
CTRI/2025/01/079479 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out how often patients need mechanical ventilation after major abdominal cancer surgeries in a specialized cancer hospital |
|
Scientific Title of Study
|
Incidence of post operative mechanical ventilation in major coelomic oncological surgeries in a tertiary care cancer Centre: A prospective observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4641_Protocol_Version_1.0_dated_10.11.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aparna Chatterjee |
| Designation |
Professor and Head, Division of Pain |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain,Main Building, Second Floor, Tata Memorial Hospital.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9322243936 |
| Fax |
|
| Email |
aparnasanjay@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Chatterjee |
| Designation |
Professor and Head, Division of Pain |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain,Main Building, Second Floor, Tata Memorial Hospital.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9322243936 |
| Fax |
|
| Email |
aparnasanjay@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharanya M |
| Designation |
Junior Resident |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Main Building, Second Floor, Tata Memorial Hospital.
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9740663549 |
| Fax |
|
| Email |
smsharanyamemana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical care and Pain, OT complex, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Department of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012, Maharashtra, India |
| 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 Aparna Chatterjee |
Tata Memorial Hospital |
Dept. of Anaesthesia, Critical Care and Pain, Major OT complex, Second Floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA |
9322243936
aparnasanjay@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Memorial Hospital Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult with age above 18 years patients undergoing elective major coelomic surgeries- Gynecology, Gastrointestinal, Urology, Thoracic oncological surgeries under General Anesthesia
|
|
| ExclusionCriteria |
| Details |
1.Emergency surgeries
2.Pediatric surgeries
3.Cases for which data pertaining to anesthesia records are missing
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of post operative mechanical ventilation in adult patients above 18 years of age undergoing elective major coelomic oncological surgeries at a tertiary referral cancer institute.
|
Postoperative until ICU discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the incidence of planned vs unplanned post operative mechanical ventilation in elective surgeries
To identify associated risk factors contributing to post operative mechanical ventilation in both planned and unplanned settings at our institute
To identify duration of post operative mechanical ventilation in the PACUand identify ICU outcome of these patients
|
Postoperative until ICU discharge |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
05/02/2025 |
| 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
|
Mechanical ventilation is a useful modality in patients who are not able to maintain the level of ventilation required for gas exchange i.e., oxygenation and carbon dioxide elimination. There are varied indications for mechanical ventilation, one of the most common being management of postoperative patients recovering from anesthesia and medications. In our institute, a tertiary oncological center, majority surgeries are major oncological surgeries. In the year 2022, our hospital performed 8643 major surgeries of which 3768 were major coelomic oncological surgeries including, 2083 Gastrointestinal, 581 gynecological, 704 thoracic, 400 urological surgeries. Most of these were done under general anesthesia, commonly involving endotracheal intubation. Usually, most patients get extubated in the operating room at the end of the surgery, however some remain intubated and get shifted to the recovery room on mechanical ventilation for a myriad of reasons, both planned and unplanned. Patients requiring unplanned post operative invasive mechanical ventilation often have multiple contributing factors including patient factors such as gender, age, ASA grading, functional status and chronic comorbidities; surgical factors such as technique, grade and urgency of surgery; anesthetic factors such as intraoperative ventilation, hemodynamic instability, vasoactive drugs, metabolic abnormalities, use of opioids and neuromuscular blockade, hypothermia, prolonged duration of surgery etc. These patients are at a higher risk for poor post operative outcomes, prolonged hospital stay and mortality risk. Thus, they pose a huge burden on patient finances and hospital resources. As very few datasets exist in our patient population, this study is planned to find the incidence as well as identify the causes of post operative mechanical ventilation in major coelomic oncological surgeries.
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