| CTRI Number |
CTRI/2026/01/100379 [Registered on: 06/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational study |
| Study Design |
Other |
|
Public Title of Study
|
A Study on the Safety and Effects of Moving ICU Patients Within the Hospital |
|
Scientific Title of Study
|
An Observational Study of safety and outcomes of ICU patients undergoing Intrahospital Transport |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 901231_Version 1.0 dated 22.09.2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shilpushp Bhosale |
| Designation |
Professor and Head, Division of Critical Care Medicine, ACTREC |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer |
| Address |
Department of Anaesthesia Critical Care and Pain, Sector 22 Utsav Chowk CISF Rd Owe Camp, ACTREC, Kharghar Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9619310657 |
| Fax |
|
| Email |
shilbhosale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpushp Bhosale |
| Designation |
Professor and Head, Division of Critical Care Medicine, ACTREC |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer |
| Address |
Department of Anaesthesia Critical Care and Pain, Sector 22 Utsav Chowk CISF Rd Owe Camp, ACTREC, Kharghar Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9619310657 |
| Fax |
|
| Email |
shilbhosale@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shilpushp Bhosale |
| Designation |
Professor and Head, Division of Critical Care Medicine, ACTREC |
| Affiliation |
Advanced Centre for Treatment, Research and Education in Cancer |
| Address |
Department of Anaesthesia Critical Care and Pain, Sector 22 Utsav Chowk CISF Rd Owe Camp, ACTREC, Kharghar Navi Mumbai
Mumbai
MAHARASHTRA
410210
India |
| Phone |
9619310657 |
| Fax |
|
| Email |
shilbhosale@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical care and Pain, OT complex, Seventh floor, RRS Building, ACTREC, Navi Mumbai - 410210 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Centre |
| Address |
Department of Anaesthesia Critical Care and Pain, ACTREC, Navi Mumbai - 410210 |
| 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 Shilpushp Bhosale |
Tata Memorial Centre |
Department of Anaesthesia Critical Care and Pain, ACTREC, Kharghar, Navi Mumbai - 410210
Mumbai
MAHARASHTRA |
9619310657
shilbhosale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee: III |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
All Adult patients (more than 18 years old) transported out of ICU for any reason will be included |
|
| ExclusionCriteria |
| Details |
Routine post op patients intended for transport (Neurosurgical patients undergoing routine
postoperative scans) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of major complications during and after transport of critically ill adults |
Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Common risk factors for complications
|
Day 1 |
2. ICU outcome at 30 days
3. Hospital outcome at 30 days
|
Day 30 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/01/2026 |
| 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="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
|
Intrahospital transport of critically ill patients is often required for diagnostic and therapeutic indications. The intrahospital journey of these patients presents with the same challenges and risks as posed by inter hospital transfer. It often adds to the increased workload and stress to the critical care staff. Major adverse events reported during transport of critically ill patients Transport of critically ill patients is potentially dangerous with up to 70 percent adverse events reported. Minimum standards for intrahospital transport of critically ill patients published in 2003 by the Joint Faculty of Intensive Care Medicine, the Australian and New Zealand College of Anaesthetists and Australasian College for Emergency Medicine. We would like to assess intrahospital transport practices and complications associated with it. Assess whether team possess the technical skills and knowledge to undertake transports. Assess safety hazards related to the work system team, tasks, tools and technologies, environment and organization. Study design Prospective Observational Cohort Study. |