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CTRI Number  CTRI/2024/06/069401 [Registered on: 24/06/2024] Trial Registered Prospectively
Last Modified On: 21/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   An observational study to analyse the effectiveness of the surgical safety checklist (a simple tool designed to improve the safety of surgical procedures) and to look at the quality of implementation of the checklist 
Scientific Title of Study   The Modified Surgical safety checklist-Effectiveness and quality of its implementation 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
4415_version 1.0 dated 22.01.2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reshma Ambulkar 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reshma Ambulkar 
Designation  Professor 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital


MAHARASHTRA
400012
India 
Phone  9821790448  
Fax    
Email  rambulkar@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vipul Vasave  
Designation  Junior Resident 
Affiliation  Tata Memorial Centre 
Address  Dept of Anaesthesia, Critical Care and Pain, Main Building, Second floor, Tata Memorial Hospital

Mumbai
MAHARASHTRA
400012
India 
Phone  9404819800  
Fax    
Email  vipulvasave19@gmail.com  
 
Source of Monetary or Material Support  
Dept of Anaesthesia, Critical care and Pain, Tata Memorial Hospital, Parel, Mumbai 400012, Maharashtra, India 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dept 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  
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  Tata Memorial Centre  Dept of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 		 9821790448

rambulkar@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  
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 
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. Surgeries performed in any of the 3 Minor OTs during routine working hours in the morning shift (8.30 am to 1 pm) in TMH.
2. Adult patients age above 18 years
 
 
ExclusionCriteria 
Details  1. Emergency procedures performed during routine working hours.
2. Patient less than or equal to 18 years without the capacity to give consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To analyse the effectiveness of the surgical safety checklist
2. To look at the quality of implementation of the checklist by studying the level of interaction between the three team members (surgeon, anaesthetist and OT nurse) involved in the implementation of the checklist. 		 From One hour preoperative until one hour postoperative 
 
Secondary Outcome  
Outcome  TimePoints 
To examine which member of the operating team (surgeon, anaesthetist, nurse) initiates the checklist  From One hour preoperative until one hour postoperative 
 
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)   08/07/2024 
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="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  

Background:

The delivery of healthcare is complex and hence riddled with the potential for errors due to human factors, system failure or combination of both. Surgery forms an important treatment modality with millions of surgical procedures performed world over. Complications are not uncommon and occur in 3% to 16% of all surgical procedures with permanent disability or mortality rates ranging between 0.4% to 0.8% of all surgical procedures.(1,2) These figures are from the Western world and it is likely that the incidence of these complications is higher in developing countries like India. Many of these complications may be due to preventable/modifiable causes.

Checklists or protocols are a common tool for preventing human errors in complex and high intensity areas of work. In 2007, the World Health Organization (WHO) launched the “Safe Surgery Saves Lives” global campaign during which it identified key processes in the operative period which could potentially affect patient outcomes. These included inadequate anaesthesia safety practices, avoidable surgical infections and poor communication among team members. Based on these processes, the WHO implemented a Surgical Safety Checklist (SSC) for briefings in the operating room.(3). 

The WHO surgical safety checklist

The checklist (Appendix – 1) consists of three main parts which are implemented at three specific time-points during the surgery: first part (sign-in) which is done before administering anaesthesia to the patient, second part (time-out) which is done before taking the surgical incision, and the third part (sign-out) done before starting closure. Each of these parts consists of certain elements/items, which have shown to improve surgical outcome, decrease complications including wrong site of surgery and finally improve patient safety (4,5). At each of these time-points, important information can be checked, communicated and shared between all team members participating in the surgery. The team members comprise of one representative from each of the following: the surgical team, the anaesthesia team and the nursing team. The patient is also involved in part in the 1st briefing. WHO has always encouraged modifications. The checklist must focus on the most critical issues, be brief and fit the local flow of care. WHO has emphasized testing changes prior to rolling them out and using local data feedback, simulation, and training as strong drivers for the implementation. 

The surgical safety checklist at TMH

The WHO has recommended that the checklist should be modified to suit local needs as mentioned above. Accordingly, at Tata Memorial Hospital (TMH), a modified version of the WHO checklist (Appendix-2) has been implemented since 2009 in Main OR and a modified version of SSC in Minor ORs. After 5 years of its implementation, we want to evaluate the effectiveness of the checklist in the minor OR by finding out which essential items in the peri-operative period were picked up by the OT team members only after they were brought up during the conduct of the checklist. In addition, errors in areas where safety is a concern are partly attributable to inadequate communication and poor teamwork.  Hence we will also study the level of interaction between the three team members (surgeon, anaesthetist and OT nurse) during the implementation of the checklist.

Need of SSC in minor OR


In our outpatient surgical and day care unit, a diverse array of procedures takes place, encompassing activities such as direct laryngoscopy, biopsies, examination under anesthesia, microlaryngeal surgeries, bronchoscope-guided biopsies, chemoport insertions, tracheostomies, simple breast surgeries, cystoscopies, and bone marrow aspiration and biopsies, among others. The patient turnover is notably high, with a majority arriving for their procedures on the same day from their homes. This environment poses distinct challenges, including suboptimal adherence to fasting guidelines, patients potentially not being fully optimized concerning their underlying health conditions, and a considerable number of surgical and anesthesia and nursing teams involved. Consequently, strict adherence to the surgical safety checklist (SSC) holds paramount importance in this context.

Methodology:

There are 3 operation theatres in our minor OT complex carrying out an average of 10 surgeries per OT per day (10). Using a random number table, we will randomly select one of the 3 OTs and 5 patients in that particular OT in the morning and will observe the implementation of the two parts of the checklist during a surgery carried out in that particular OT. A member of the investigating team, (a trained research nurse) will be present in the selected operation theatre from the time the patient is wheeled in. The research nurse will passively observe the implementation of the check list. He/she will not actively participate or talk to the team members implementing the check list or correct any errors.

Out of the two parts of the checklist, we intend to study 8 elements in the first two parts i.e. sign-in, sign-out of the checklist, which are crucial to patient safety.

Following elements from the first part will be studied:

·       Confirmation of patient, name and side of operation (As part of patient safety to avoid operation on wrong patient and wrong side)

·       Patient Consent

·       Viral Markers checked?

·       Pulse oximetry functioning or not

·       Is there any anticipated difficult airway (The team will recognise and effectively prepare for life-threatening loss of airway)

·       Fasting adequacy

·       Any known allergy

·       Any other concerns from the team

For each of these items, the research nurse will document whether

1.       There was compliance with the checklist

2.       Whether the checklist prompted any change in behaviour (e.g. checking the file for site of surgery, checking consent, viral markers, putting pulse oxymeter on patient, asking about fasting and allergy, examining the airway)

3.       Whether members of all three teams needed for the checklist were present and participating actively in the implementation of the checklist

Sample size and statistical analysis

This is an observational study. A convenience sample of 200 cases (surgeries) will be selected. We plan to study 5 surgeries per working day. Therefore, we will complete the study in around 6 months. Data will be expressed as percentages for categorical data and means / medians for continuous data.

 
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