| CTRI Number |
CTRI/2024/07/070693 [Registered on: 16/07/2024] Trial Registered Prospectively |
| Last Modified On: |
10/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Adverse Events during Intrahospital Transport of Critically
Ill Patients |
|
Scientific Title of Study
|
To study the incidence of adverse events during intrahospital transport of critically ill patients A prospective observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shagun Guleria |
| Designation |
Resident |
| Affiliation |
Indira Gandhi Medical College shimla |
| Address |
Block C
Department of Anesthesia
Indira Gandhi Medical College, Shimla
Shimla
HIMACHAL PRADESH
Shimla
HIMACHAL PRADESH
171003
India |
| Phone |
9459621874 |
| Fax |
|
| Email |
shagunguleria1377@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Sood |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Government Medical College , shimla |
| Address |
Department of Anesthesia, Indira Gandhi Medical College, Shimla
Shimla
HIMACHAL PRADESH
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418028130 |
| Fax |
|
| Email |
ajay_5644@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Sood |
| Designation |
Professor |
| Affiliation |
Indira Gandhi Government Medical College , shimla |
| Address |
Department of Anesthesia, Indira Gandhi Medical College, Shimla
Shimla
HIMACHAL PRADESH
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418028130 |
| Fax |
|
| Email |
ajay_5644@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Medical College, Shimla, Himachal Pradesh, India PIN CODE-171001 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Government Medical College |
| Address |
Indira Gandhi Medical College, Lakkar Bazaar road, Shimla, Himachal Pradesh, India PIN CODE 171001 |
| 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 |
| Dr Ajay Sood |
Indira Gandhi Government Medical College ,Shimla |
Operation theatre complex
Department of Anaesthesia and critical care
Indira Gandhi Medical College
Lakkar Bazzar road
Shimla
Himachal Pradesh
Pin 171001
India
Shimla
HIMACHAL PRADESH |
9418028130
ajay_5644@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Indira Gandhi Government Medical College ,Shimla |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z998||Dependence on other enabling machines and devices, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1)All critically ill patients of every age who underwent intrahospital transport are included in the study
2)All critically ill patients of either gender who underwent intrahospital transport are included in the study |
|
| ExclusionCriteria |
| Details |
1)Refusal to participate in study
2)patients who are not critically ill |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyse adverse events during intrahospital transport of critically illl patients and study patient outcome (survival or death ) within 24 hr . |
1) before transport for 15 min
2 During transport
3) after returning to ICU for 15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To determine the nature of problems encountered during intrahospital transport.
2) Preventive strategies which could be put in place to reduce observed adverse events. |
1) before transport
2 During transport
3) after returning to ICU |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/07/2024 |
| 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 Yet Recruiting |
| 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
|
This protocol has been prepared as per STROBE (Strengthening the Reporting of Observational studies in Epidemiology) guidelines. After approval from the ethics committee, IGMC Shimla and obtaining the CTRI number, the patients will be recruited in the study following informed written consent by the patients themselves or from the next of their kin . The study cohort will include all critically ill patients of all age group . All qualitative variables will be noted before transport, during transport and after receiving patient in ICU . All qualitative variables Will be tabulated and analysed as frequency and percentage. |