CTRI Number |
CTRI/2025/05/086205 [Registered on: 02/05/2025] Trial Registered Prospectively |
Last Modified On: |
02/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Prospective Observational study |
Study Design |
Other |
Public Title of Study
|
Making Surgery Safer by tracking quality to improve patient care |
Scientific Title of Study
|
Quality IndicatorS for improving pAtient care and eFficiEncy in OR |
Trial Acronym |
SAFE |
Secondary IDs if Any
|
Secondary ID |
Identifier |
901125_Protocol V 1.1 dated 17.03.25 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Reshma Ambulkar |
Designation |
Professor and Head |
Affiliation |
Tata Memorial Centre |
Address |
Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar
Raigarh MAHARASHTRA 410210 India |
Phone |
9821790448 |
Fax |
|
Email |
rambulkar@hotmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Reshma Ambulkar |
Designation |
Professor and Head |
Affiliation |
Tata Memorial Centre |
Address |
Department of Anesthesia Critical Care and Pain, Advanced Centre for Treatment, Research and Education in Cancer, Kharghar
Raigarh MAHARASHTRA 410210 India |
Phone |
9821790448 |
Fax |
|
Email |
rambulkar@hotmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Yasasvini A |
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 |
8778165329 |
Fax |
|
Email |
yashu100597@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, MAHARASHTRA 410210 India |
|
Primary Sponsor
|
Name |
Tata Memorial Hospital |
Address |
Department of Anesthesia Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012 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 Reshma Ambulkar |
ACTREC |
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 Raigarh MAHARASHTRA |
9821790448
rambulkar@hotmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Tata Memorial Centre Institutional Ethics Committee III |
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
|
Type |
Name |
Details |
Comparator Agent |
Nil |
Nil |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
0.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
1.All patients undergoing elective surgeries during the study period.
2.Patients undergoing re-exploration procedures within 48 hours from first surgery
3.All patients undergoing Pre-Anaesthesia checkup during the study period
|
|
ExclusionCriteria |
Details |
1. Patients undergoing re-exploration procedures after 48 hours from first surgery
2. Patients posted in minor OT, IR OT are not included in the study
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To evaluate perioperative practices using an array of quality indicators and to compare the indicators against the benchmarks established at institutional and national levels. |
Preoperative and Intraoperative phase |
|
Secondary Outcome
|
Outcome |
TimePoints |
To identify areas of improvement for the same |
Preoperative and Intraoperative phase |
|
Target Sample Size
|
Total Sample Size="750" Sample Size from India="750"
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)
|
15/05/2025 |
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
|
Patient safety is paramount in the medical field to mitigate risks, errors, and harm associated with healthcare delivery. The complexity of treatments and the potential for adverse events such as infections, medication errors, and surgical complications underscore the significance of ensuring safety in hospitals. Implementing measures to enhance patient safety entails establishing a robust safety culture, adopting evidence-based practices, leveraging technology, and promoting continuous quality improvement. Operating theaters, as the most efficient sector within hospitals, should be particularly vigilant to minimize inefficiencies, as they can directly increase patient risks. To effectively monitor and assess the quality of healthcare, well-defined quality indicators are essential. These measurable elements of healthcare performance are selected based on empirical evidence or expert consensus. Accreditation organizations globally, such as the National Accreditation Board for Hospitals and Healthcare Providers (NABH) and the Indian Society of Critical Care Medicine (ISCCM), play a crucial role in enhancing healthcare quality by establishing robust systems of checks and balances and managing certification programs for existing healthcare systems.This prospective, observational study will be conducted in the Pre-Anesthesia Clinic and Operation Theaters of ACTREC, TMC, Mumbai. The study’s objective is to evaluate perioperative practices using a comprehensive array of quality indicators and compare them against benchmarks established at both institutional and national levels. Indicators to be assessed are as follows: Time taken for Assessment of patient in PAC and pain clinic, Percentage of patients who received prophylactic antibiotics within the specified time frame, Percentage of incomplete consent for surgery and anesthesia, Percentage of postponement of surgeries, Percentage of near misses in operation theater, Percentage of unplanned return to OT, Average Time from order of blood to receiving it, Average time from sample sent in rush to receiving blood report, Percentage of Unplanned postoperative ventilation, OT utilisation rate, Anesthesia induction time, Average Operation theatre turnaround time. |