| CTRI Number |
CTRI/2024/07/071056 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
22/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to assess complications in critically ill patients during transport within the hospital to and from ICU.
|
|
Scientific Title of Study
|
Complications in critically ill patients during intra-hospital transport to and from ICU. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Asim Siddiqui |
| Designation |
Junior Resident Doctor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh.
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9760329951 |
| Fax |
|
| Email |
drsiddiquiasim09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abu Nadeem |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9837757772 |
| Fax |
|
| Email |
drabunadeem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Asim Siddiqui |
| Designation |
Junior Resident Doctor |
| Affiliation |
Jawaharlal Nehru Medical College, Aligarh Muslim University |
| Address |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh.
Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9760329951 |
| Fax |
|
| Email |
drsiddiquiasim09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care,Jawaharlal Nehru Medical College Hospital, Aligarh Muslim University, Aligarh-202001, Uttar Pradesh, India.
|
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care JNMCH AMU |
| Address |
Department of Anaesthesiology and Critical Care,JNMCH, AMU Aligarh- 202001, Uttar Pradesh, India
|
| 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 Mohammad Asim Siddiqui |
Jawaharlal Nehru Medical College AMU |
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University
Aligarh
UTTAR PRADESH |
9760329951
drsiddiquiasim09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jawaharlal Nehru Medical College AMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients (18years old) admitted to ICU who are unstable.
Unstable included requiring high oxygen therapy, mechanical ventilation or vasoactive medications, patients with poly-trauma (not on ventilator or vasopressors) with chest drains, EVDs , patients with C spine injury with collar.
Low GCS/ combative patients.
Patients with arrhythmias on infusions.
|
|
| ExclusionCriteria |
| Details |
All adult patients less than 18 years old admitted to ICU.
Critically ill patients who are not on vasopressors or oxygen therapy with no drains and haemodynamically stable.
Those who are not willing to give consent
Pregnant Patients
All patients who are shifted from elective OT to ICU are not included.
Patients who are discharged from the ICU and transported out of the hospital are not included.
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of major complications during and after transport of critically ill adults such as
Haemodynamic instability which means SBP less than 90 mmHg, or MAP less than 65 mmHg, or need for addition of, or increase in doses of vasopressor agents
Worsening of respiratory status
Accidental extubation, accidental removal of Inter costal drains, abdominal drains
Worsening of GCS as compared to pre-transport condition
|
At baseline of shifting a patient to or from ICU.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Malfunction of any of the transport equipment.
Whether a change in management occurred as a result of the transport, particularly for imaging, such as insertion of new drainage catheters or pigtail catheters, surgery or change of antimicrobial agents.
|
In 24 hrs since beginning of shifting patient to or from 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)
|
02/08/2024 |
| 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="2"
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
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Brief Summary
|
All consecutive adults critically ill patients requiring transport in & out of the ICU (as per inclusion criteria of this study) will be included in the study. A written informed consent will be obtained from the LAR followed by deferred consent from the patient will be obtained for inclusion of the patient data in the study. STATISTICAL ANALYSIS PLAN: We need the incidence of complications, common indications for transport, and predictors of complications and predictors of outcomes to be calculated. A simple descriptive analysis would be planned by me and then univariate and multivariate analysis.
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