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CTRI Number  CTRI/2024/01/061658 [Registered on: 19/01/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   When ultrasound guided percutaneous tracheostomy is to be done, is it better to do ultrasound pre-procedure or in real-time? 
Scientific Title of Study   Comparison of pre-procedure vs real-time ultrasound guided percutaneous dilatational tracheostomy assessed by tracheal view using flexible endoscope 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abraham Lalchhana Chawnchhim 
Designation  Assistant Professor, Dept of Anaesthesiology 
Affiliation  Army Medical Corps 
Address  Dept of Anaesthesiology, Command Hospital EC, Alipore, Kolkata.
Command Hospital EC, Alipore, Kolkata, WB 700027
Kolkata
WEST BENGAL
700027
India 
Phone  7507973615  
Fax    
Email  lalchhana2312@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Abraham Lalchhana Chawnchhim 
Designation  Assistant Professor, Dept of Anaesthesiology 
Affiliation  Army Medical Corps 
Address  Dept of Anaesthesiology, Command Hospital EC, Alipore, Kolkata.
Command Hospital EC, Alipore, Kolkata, WB 700027
Kolkata
WEST BENGAL
700027
India 
Phone  7507973615  
Fax    
Email  lalchhana2312@gmail.com  
 
Details of Contact Person
Public Query  
Name  Abraham Lalchhana Chawnchhim 
Designation  Assistant Professor, Dept of Anaesthesiology 
Affiliation  Army Medical Corps 
Address  Dept of Anaesthesiology, Command Hospital EC, Alipore, Kolkata.
Command Hospital EC, Alipore, Kolkata, WB 700027
Kolkata
WEST BENGAL
700027
India 
Phone  7507973615  
Fax    
Email  lalchhana2312@gmail.com  
 
Source of Monetary or Material Support  
Command Hospital EC, Alipore, Kolkata-700027  
 
Primary Sponsor  
Name  Command Hospital EC 
Address  Department of Anaesthesiology, Command Hospital EC, Alipore, Kolkata, WB 700027 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abraham Lalchhana Chawnchhim  Command Hospital EC  ICU, Command Hospital EC, Alipore, Kolkata, WB- 700027
Kolkata
WEST BENGAL 		 7507973615
0
lalchhana2312@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G931||Anoxic brain damage, not elsewhereclassified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bronchoscopy  Bronchoscopy will be done in all patients to enhance safety of percutaneous tracheostomy and to assess the accuracy of the initial puncture 
Intervention  Percutaneous tracheostomy  All patients require percutaneous tracheostomy as a part of their treatment 
Comparator Agent  pre-procedure ultrasound vs real-time ultrasound  Use of ultrasound to map and guide initial needle puncture during percutaneous tracheostomy can be either done: pre-procedure or real time, they are being compared as an adjunct, and accuracy will be assessed during the procedure by using bronchoscopy. 
Intervention  Ultrasound  Comparison of pre-procedure ultrasound vs Real-time ultrasound of airways to aid percutaneous tracheostomy will be done. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adult patient in our ICU planned for percutaneous tracheostomy 
 
ExclusionCriteria 
Details  Bleeding disorder
infection at the proposed puncture site
Unwillingness 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Accuracy of first puncture. Graded 1 is central puncture, Grade 2 is not grade 1 but still acceptable and visible by bronchoscope and grade 3 where puncture needle is not visualized.  On the first attempted puncture by puncture needle. 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken for the procedure from positioning to successful tracheal puncture  Will be recorded by an observer during the procedure 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/02/2024 
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)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    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 - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Data requestors will need to request to either the investigators or the publishers who published the study

  6. For how long will this data be available start date provided 01-07-2025 and end date provided 30-06-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Adult endotracheally intubated patients in ICU who required tracheostomy will be recruited, after informed consent from next of kin. Patients will be randomized to pre-procedure vs real-time ultrasound guided percutaneous tracheostomy group. Accuracy of tracheal puncture will be assessed by tracheal view using flexible endoscope and compared between the two groups. Time taken to perform the percutaneous tracheostomy will also be compared between the groups. 
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