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CTRI Number  CTRI/2025/11/097408 [Registered on: 13/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare a small-bore chest tube versus a wide-bore chest tube for draining blood and air from chest after chest trauma. 
Scientific Title of Study   A randomized control trial comparing the efficacy of small-bore 14-French (14Fr) pigtail catheters versus 28-32Fr chest tubes in management of traumatic hemothorax & hemopneumothorax. 
Trial Acronym  PIT-STOP trial. (Pigtail catheters In Trauma- 14Fr Small-bore Tube Outcomes in Patients) 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjali Rangnani 
Designation  Senior resident  
Affiliation  Christian Medical College, Vellore 
Address  CMC Ranipet Housing Quarters, Ranipet Kilminnal Village, Ranipet, Vellore, Tamil Nadu

Vellore
TAMIL NADU
632517
India 
Phone  8411825000  
Fax    
Email  anjali_rangnani@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Anjali Rangnani 
Designation  Senior resident  
Affiliation  Christian Medical College, Vellore 
Address  CMC Ranipet Housing Quarters, Ranipet Kilminnal Village, Ranipet, Vellore, Tamil Nadu

Vellore
TAMIL NADU
632517
India 
Phone  8411825000  
Fax    
Email  anjali_rangnani@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Anjali Rangnani 
Designation  Senior resident  
Affiliation  Christian Medical College, Vellore 
Address  CMC Ranipet Housing Quarters, Ranipet Kilminnal Village, Ranipet, Vellore, Tamil Nadu


TAMIL NADU
632517
India 
Phone  8411825000  
Fax    
Email  anjali_rangnani@yahoo.co.in  
 
Source of Monetary or Material Support  
Christian Medical College, IDA Scudder road, Vellore, Tamil Nadu, India- 632004 
 
Primary Sponsor  
Name  Dr Anjali Rangnani 
Address  Christian Medical College, Ida Scudder road, Vellore, Tamil Nadu, India-632004 
Type of Sponsor  Private 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 Anjali Rangnani  Christian Medical College  Ida Scudder road, Vellore, Tamil Nadu
Vellore
TAMIL NADU 		 8411825000

anjali_rangnani@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Silver Ethics and Research Committee, Christian Medical College Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S272||Traumatic hemopneumothorax, (2) ICD-10 Condition: S271||Traumatic hemothorax,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Intercostal drain tube: size 28-32 French  size 28-32 French 
Intervention  pigtail catheter 14 French  pigtail catheter of 14 French sized will be used 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Age more than 18 years
2. Blunt chest trauma
3. Any isolated chest injury or polytrauma with traumatic hemothorax or hemopneumothorax requiring drainage (more than 300 mL on CT scan thorax. However, not all patients would receive computed tomography scans quantifying this amount when it is obvious on chest xray or ultrasonography). 
 
ExclusionCriteria 
Details  1. Penetrating chest trauma
2. Chest drain insertion more than24 hours after the trauma
3. Isolated pneumothorax
4. Placement of the chest drain was primarily for drainage of pneumothorax in the hemopneumothorax.
5. Pregnant patients
6. Death on arrival 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Failure rates of drainage catheters, requiring change of the tube.  12 hours, 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Total drain output
 		 1 hour, 12 h(hours), 24 h and 48 h.
 
Pain score assessment using Numerical Rating Scale (NRS) at the tube site
 		 at the time of tube insertion. (5 minutes) 
Tube related complications.  48 hours 
Total tube days  10 days 
Total ventilator days.
Intensive care unit (ICU) & hospital length of stay (HLOS). 		 10 days 
 
Target Sample Size   Total Sample Size="182"
Sample Size from India="182" 
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   Phase 4 
Date of First Enrollment (India)   30/11/2025 
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="6"
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 - 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 -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [anjali_rangnani@yahoo.co.in].

  6. For how long will this data be available start date provided 15-11-2025 and end date provided 26-12-2028?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This trial is to compare 14 French pigtail catheter (new treatment) versus the usual recommended treatment with 28 to 32 French chest tubes in case of traumatic hemothorax or hemopneumothorax. A few studies have shown that 14 French pigtail catheter was equally efficacious in draining hemothorax or hemopneumothorax in case of blunt chest trauma as that of 28 to 32 French chest tubes. The benefit of using 14 French pigtail catheters is that they are small bore catheters, associated with lesser pain and better patient comfort, while being equivalent to the wide bore chest tubes, which is recommendations by ATLS. Thus we aim to compare the efficacy of 14 French pigtail catheters in terms of failure rates, versus 28 to 32 French chest tubes in draining traumatic hemothorax or hemopneumothorax in blunt chest trauma 
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