| CTRI Number |
CTRI/2025/02/079911 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
A prospective, online questionnaire |
| Study Design |
Other |
|
Public Title of Study
|
online survey on safety practices in operation theatre in a cancer hospital |
|
Scientific Title of Study
|
An online survey on safe operating room practices in tertiary care cancer
hospitals in India |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 901101_Version 1.2 dated 02.12.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Reshma Ambulkar |
| Designation |
Professor & Head |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical Care and Pain,
Advanced Centre for Treatment, Research and Education in Cancer, Kharghar,Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
9821790448 |
| Fax |
|
| Email |
rambulkar@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Reshma Ambulkar |
| Designation |
Professor & Head |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical Care and Pain,
Advanced Centre for Treatment, Research and Education in Cancer, Kharghar,Navi Mumbai
Raigarh MAHARASHTRA 410210 India |
| Phone |
9821790448 |
| Fax |
|
| Email |
rambulkar@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ashish Lokhande |
| Designation |
Junior Resident 2 |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical care and Pain, Tata Memorial Hospital, Parel Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
7020729201 |
| Fax |
|
| Email |
lokhandeashish123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia Critical Care and Pain,
Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, 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 Reshma Ambulkar |
Advanced Centre for Treatment, Research and Education in Cancer |
Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar, Navi Mumbai Raigarh MAHARASHTRA |
9821790448
rambulkar@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| HOMI BHABHA CANCER HOSPITAL AND RESEARCH CENTRE NEW CHANDIGARH IEC |
Approved |
| Homi Bhabha Cancer Hospital and Research Centre Vizag |
Submittted/Under Review |
| MAHAMANA PANDIT MADAN MOHAN MALAVIYA CANCER CENTRE AND HOMI BHABHA CANCER HOSPITAL |
Approved |
| Tata Memorial Centre Institutional Ethics Committee III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Operation Room Personnel |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
Nil |
| Comparator Agent |
NA |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All operation room personnel (ORP) concerned with patient care (Surgeons,
Anesthetists, Nursing staff and OR technicians) will be asked to participate |
|
| ExclusionCriteria |
| Details |
Individuals not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the patient safety culture of OR personnel who are concerned with patient care. |
one time online responses obtained through questionnaires over 6 months duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comprehensive analysis of operational, procedural, and cultural factors influencing safe operating room practices |
One time survey |
|
|
Target Sample Size
|
Total Sample Size="1000" Sample Size from India="1000"
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)
|
20/02/2025 |
| 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) |
Open to Recruitment |
|
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 study title, “An online survey on safe operating room practices in tertiary care cancer hospitals in India”, is designed to assess the patient safety culture of Operating Room Personnel (Surgeons, Anesthetists, Nursing staff and OR technicians) who are concerned with patient care. Quality healthcare, especially patient safety, is crucial worldwide as this involved in prevention of medical errors that can lead to disastrous outcome. Errors in the operating room (OR) can include performing surgery on the wrong site, leaving instruments inside the body, medication error, delays in starting procedures, or infections from improper sterilization. These issues often arise due to poor communication, lack of resources, or failure to follow safety protocols. In India, where healthcare settings vary widely, these challenges can be even more pronounced, particularly in tertiary care cancer hospitals that handle complex cases. At Tata Memorial Centre, where complex surgeries are not so uncommon, operating room personnel face high-risk situations and are prone to errors. Assessing their safety attitudes is vital for improving patient safety. We will use the Safety Attitudes Questionnaire (SAQ) to measure the safety perceptions of Operating Room Personnel (ORP) across Tata Memorial Centre. This study aims to understand and improve the safety culture in operating rooms through a detailed survey. |