| CTRI Number |
CTRI/2026/02/104717 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Other (Specify) [Patient handover checklist ] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Using a structured checklist during patient transfers to reduce breathing risks in adults after anesthesia surgery breathing safety |
|
Scientific Title of Study
|
A Randomized Control trial to compare Structured Handover Checklists (PATH) vs conventional (SBAR) handover for Post-Anesthesia incidence of Hypoxia in adult patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DAVINDER JIT SINGH |
| Designation |
Assistant professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesia and Critical Care, Block 5, 5th floor, Room no 531, Command Hospital Pune
Pune MAHARASHTRA 411040 India |
| Phone |
08728055241 |
| Fax |
|
| Email |
davinderjit98@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DAVINDER JIT SINGH |
| Designation |
Assistant professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesia and Critical Care, Block 5, 5th floor, Room no 531, Command Hospital Pune
MAHARASHTRA 411040 India |
| Phone |
08728055241 |
| Fax |
|
| Email |
davinderjit98@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DAVINDER JIT SINGH |
| Designation |
Assistant professor |
| Affiliation |
Armed Forces Medical College |
| Address |
Department of Anaesthesia and Critical Care, Block 5, 5th floor, Room no 531, Command Hospital Pune
MAHARASHTRA 411040 India |
| Phone |
08728055241 |
| Fax |
|
| Email |
davinderjit98@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical Services |
| Address |
Command hospital Pune, Dept Of Anaesthesia 5th floor block 3 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DAVINDER JIT SINGH |
Command Hospital Southern Command |
Post Anaesthesia Care Unit Pune MAHARASHTRA |
08728055241
davinderjit98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, Armed Forces College, Solapur Road Pune |
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 |
| Intervention |
Post Anaesthesia Team handover (PATH) Checklist |
PATH based patient handover from Operation theater to Post-anaesthesia care unit Duration- from time of admission to discharge from post anaesthesia care unit |
| Comparator Agent |
Situation Background Assessment Recommendation (SBAR) checklist |
SBAR based conventional patient handover from Operation theater to Post-anesthesia care unit. Duration- from time of admission to discharge from post anaesthesia care unit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
patients scheduled to undergo elective surgical operative procedures under general or regional anaesthesia. |
|
| ExclusionCriteria |
| Details |
Direct ICU transfers, acute or chronic preoperative respiratory failure and duration of surgery more than 8 hours. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Structured Handover Checklists (PATH) Vs conventional (SBAR) handover for Post-Anaesthesia incidence of Hypoxia. |
To compare Structured Handover Checklists (PATH) Vs conventional (SBAR) handover for Post-Anaesthesia incidence of Hypoxia.Time points- T0- arrival to PACU, T1- 5min, T2-10min, T3- 20min, T4- 30 min in PACU |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess postoperative variations in hemodynamic parameters, nausea/vomiting, pain, length of stay in PACU, duration of handover & number of phone calls made to OT team till the patient is monitored in the PACU. |
Time points- T0- arrival to PACU, T1- 5min, T2-10min, T3- 20min, T4- 30 min in PACU |
|
|
Target Sample Size
|
Total Sample Size="690" Sample Size from India="690"
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)
|
15/03/2026 |
| 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="6" 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [davinderjit98@gmail.com].
- For how long will this data be available start date provided 01-03-2026 and end date provided 01-03-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Miscommunication remains a major contributor to preventable incidents in healthcare, despite the development of numerous checklists aimed at improving patient outcomes. Notably, the 2009 WHO surgical safety checklist demonstrated significant reductions in morbidity and mortality. Building on this success, our objective is to evaluate whether implementing a post anesthesia team handover (PATH) checklist could effectively reduce hypoxemic events within the Post-Anesthesia care Unit (PACU). This trial will evaluate two handover methods to improve patient safety by reducing hypoxic events and enhancing communication quality during postoperative care. The project includes clinician training, standardized handover formats and monitoring of patient outcomes over a 18 month period. |