| CTRI Number |
CTRI/2025/07/090960 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Study looking at effective communication of information while shifting postoperative patients from operating rooms to ICU and Assessing the effect of training on the quality of this communication. |
|
Scientific Title of Study
|
HOPE Audit:Assessing Handover Practices In Post Anaesthesia Care Unit,And The Impact Of Training On The Quality Of Handovers. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Malini Joshi |
| Designation |
Professor and Consultant, Department of Anesthesia,Critical Care and Pain, ACTREC,Tata Memorial Centre |
| Affiliation |
ACTREC,Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
MAHARASHTRA
410210
India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Malini Joshi |
| Designation |
Professor and Consultant, Department of Anesthesia,Critical Care and Pain, ACTREC,Tata Memorial Centre |
| Affiliation |
ACTREC,Tata Memorial Centre |
| Address |
ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
MAHARASHTRA
410210
India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9987226657 |
| Fax |
|
| Email |
jmalini2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Padalwar |
| Designation |
Junior Resident, Department of Anesthesia, Critical Care and Pain, Tata Memorial Centre |
| Affiliation |
Tata Memorial Centre |
| Address |
Dept of Anaesthesiology, Critical Care and Pain, 7th floor, Rajarao Shodhika Building, ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai MAHARASHTRA
410210
India
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9421045955 |
| Fax |
|
| Email |
pallavipadalwar103@gmail.com |
|
|
Source of Monetary or Material Support
|
| ACTREC,Tata Memorial Centre,Navi Mumbai,
410210
MAHARASHTRA
INDIA |
|
|
Primary Sponsor
|
| Name |
ACTREC Tata Memorial Centre |
| Address |
ACTREC Tata Memorial Centre, Sector 22, Kharghar Navi Mumbai
410210
Maharashtra
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 Malini Joshi |
Tata Memorial Centre |
Dept of Anaesthesiology, Critical Care and Pain, 7th floor, Rajarao Shodhika Building, ACTREC, Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai
410210
MAHARASHTRA
India
Mumbai
MAHARASHTRA |
9987226657
jmalini2007@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACTREC ,Institutional Ethical Committee 3 |
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 |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All handovers in the Post Anaesthesia Care Unit (PACU)carried out in routine hours (9am-6pm),including elective and emergency surgeries. |
|
| ExclusionCriteria |
| Details |
Patients shifted from the wards for medical management. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of handovers by ISBAR technique before and after training. |
Handover practices observed for 3 months followed by training programme and then again observed for 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of adverse events related to handover errors, nurses perception of handover effectiveness, association of outcomes with poor handover compliance, Incidence of unanticipated transfer to ICU from post anaesthesia care unit(PACU) |
Handover practices observed for 3 months followed by training programme & then again observed for 3 months |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
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)
|
25/08/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
The purpose of this study is this Audit will evaluate the current handover Practices in the PACU and assess the effectiveness and compliance to handover checklist and effect of training in improving the handover Practices. It is a prospective observational study to be conducted over a period of 6 months in PACU of Tata Memorial Centre ACTREC The Audit will include all surgical patients transferred from the operating room to post anaesthesia care unit ( PACU)between 9am -6pm,both emergency and electivecases. During the study period data collection will be done by independent observer (Research nurse) in the PACU who is not a Part of the handover process.The observer will record the staff involved in the handover process (Anaesthesiologist,surgeons,nurses) This Audit will also help to identify, improve and optimize handover efficiency and reduce errors. |