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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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