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CTRI Number  CTRI/2022/10/046354 [Registered on: 11/10/2022] Trial Registered Prospectively
Last Modified On: 20/02/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Intrahospital transport of unstable critically sick patients 
Scientific Title of Study   Intra-hospital Transport of Unstable Critical care Hospitalized patient A Practice Pattern Observational Multicenter Study ( I TOUCH study) 
Trial Acronym  I TOUCH 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr KapilG Zirpe 
Designation  HOD 
Affiliation  ISCCM 
Address  Neuro trauma unit,40 Sasson road,Ruby Hall Clinic,Pune
Unit 13 and 14 ,First Floor,Hind Service Industries premises Cooperative society,off veer savarkar marg,dadar,mumbai
Mumbai
MAHARASHTRA
411001
India 
Phone  9822844212  
Fax    
Email  kapilzirpe@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr AnandMTiwari 
Designation  Senior Consultant 
Affiliation  ISCCM 
Address  Neuro trauma unit,40 Sasson road,Ruby Hall Clinic,Pune
Unit 13 and 14 ,First Floor,Hind Service Industries premises Cooperative society,off veer savarkar marg,dadar,mumbai
Mumbai
MAHARASHTRA
411001
India 
Phone  7798255626  
Fax    
Email  dranandtiwari@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr AnandMTiwari 
Designation  Senior Consultant 
Affiliation  ISCCM(Indian society of critical care medicine) 
Address  Neuro trauma unit,40 Sasson road,Ruby Hall Clinic,Pune
Unit 13 and 14 ,First Floor,Hind Service Industries premises Cooperative society,off veer savarkar marg,dadar,mumbai
Mumbai
MAHARASHTRA
411001
India 
Phone  7798255626  
Fax    
Email  dranandtiwari@gmail.com  
 
Source of Monetary or Material Support  
Indian Society Of Critical Care Medicine Unit 13 and 14 First Floor Hind Service Industries Premises Cooperative Society Near Chaitya Bhoomi Off Veer Savarkar Marg Dadar Mumbai 400028 
 
Primary Sponsor  
Name  ISCCM 
Address  UNIT 13 and 14 First Floor,Hind Service Industries premises cooperative society,off veer savarkar marg,dadar,mumbai 400028 
Type of Sponsor  Other [non profit organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sharmili sinha   Apollo hospital   plot no 25,samanta puri ,sainik school road ,unit 15 pin--751005
Khordha
ORISSA 		 986155079

sharmili.sinha@yahoo.co.in 
Dr Mahesh p   manipal hospital  98,old airport road ,kodhalli ,bangalore
Bangalore
KARNATAKA 		 9448843933

padyana@gmail.com 
Dr Deepak govil   medhanta hospital   sector 38,gurgaon ,Haryana pin--560017
Gurgaon
HARYANA 		 9818056688

drdeepak_govil@yahoo.co.in 
Dr Anand Tiwari  Neuro trauma unit , department Sanghvi building, first floor office 101 Ruby hall clinic  40 Sasson road,
Pune
MAHARASHTRA 		 7798255626

dranandtiwari@gmail.com 
Dr Subhal dixit   sanjeevan hospital   plot 23 ,off karve road erandavane pin--411004
Pune
MAHARASHTRA 		 9822050240

subhaldixit@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Biomedical and Health Research,Poona Medical Research Foundation   Approved 
ethics commitee of manipal hospital  Approved 
Instititional Ethics Committee, Apollo Hospital Guwahati  Approved 
Instititional Ethics Committee, Bharati Vidyapeeth Pune  Approved 
Instititional Ethics Committee, Care Hospital Hyderabad  Approved 
Instititional Ethics Committee, Fortis Hospital Noida  Approved 
Instititional Ethics Committee-Biomedical research Apollo Hospital Hyderabad  Approved 
Instititional Ethics Committee-Biomedical research Tagore hospital and heart care centre Pvt Ltd  Approved 
Institutional ethics commitee Sanjeevan hospital  Approved 
Institutional Ethics Committee Max Super Speciality Hospital Delhi  Approved 
Medanta institutional ethics commiTtee  Approved 
Santosh deemed to be university  Approved 
The Institution ethics committee biomedical research Apollo Hospitals,Bhubaneshwar  Approved 
Virinchi Hospitals Institutional Ethics Committee Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Y69||Unspecified misadventure during surgical and medical care,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients (> 18years old) admitted to ICU who are unstable conditions as below-

1.Unstable included requiring oxygen therapy, mechanical ventilation or vasoactive medications.

2.patients with poly trauma ( not on ventilator/ vasopressors) with chest drains, EVDs(External ventricular drains) , patients with C spine injury with collar.

3.post operative patients with abdominal drains.

4.low GCS(Glasgow coma scale) / combative patients

5.patients with arrhythmias on medication infusions.

 
 
ExclusionCriteria 
Details  1.All adult patients (< 18years )old admitted to ICU.
2.ICU patients who are not on vasopressors or oxygen therapy with no drains and hemodynamically stable with NSR (Normal sinus rhythm)

3.Those who are not willing to give consent

4.Pregnant patients

5.Patient with psychiatric illness
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Incidence of major cardiorespiratory complications during and after transport of critically ill adults,
Accidental extubation, accidental removal of Inter costal drains, abdominal drains
Increase in hemorrhage
Worsening of GCS as compared to pre-transport condition
 		 clinical condition @ 24 hr 
 
Secondary Outcome  
Outcome  TimePoints 
Common indications for transport
Any other complications not included in the primary outcomes
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
 		 ICU outcome/discharge 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="1000" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2022 
Date of Study Completion (India) 20/02/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swap1592@gmail.com].

  6. For how long will this data be available start date provided 01-04-2023 and end date provided 01-05-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Intra-hospital transport of critically ill patients is often required for diagnostic and therapeutic indications. Intra-hospital journey of these patients presents with the same challenges and risks as posed by inter hospital transfer .[1] It often adds to the increased workload and stress to the critical care staff .[2] Major adverse events reported during transport of critically ill patients. Despite presence of several guidelines and few recommendations [3] , there has been no consensus regarding the ideal practice guidelines for intra hospital transport in critically ill patients. We would like to collect data prospectively from various ICUs across the country regarding the practice of intra hospital transport in unstable adult critical care patients and various complications associated in a 90-day study period .We would like to assess intra hospital transport practices and complications associated in an attempt to define the ideal ISCCM consensus statement regarding intra hospital transport of critically ill hospitalized patients.
 
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