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CTRI Number  CTRI/2024/09/074167 [Registered on: 23/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing the Effects of Clamping vs. Not Clamping Chest Drains Before Removal on the Need for Future Drainage in Pneumothorax Patients 
Scientific Title of Study   Assessing the Effect of Intercostal Drain Clamping Prior to Removal versus No Clamping on Subsequent Ipsilateral Invasive Pleural Drainage in Pneumothorax Patients: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ruchi Dua 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Pulmonary Medicine, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249203, India

Dehradun
UTTARANCHAL
249203
India 
Phone  7895973469  
Fax    
Email  ruchi.pulm@aiimsrishikesh.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Shivam Garg 
Designation  Senior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Pulmonary Medicine, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249203, India

Dehradun
UTTARANCHAL
249203
India 
Phone  8575108929  
Fax    
Email  shivjmv@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ruchi Dua 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Pulmonary Medicine, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249203, India

Dehradun
UTTARANCHAL
249203
India 
Phone  7895973469  
Fax    
Email  ruchi.pulm@aiimsrishikesh.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249 203, India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Department of Pulmonary Medicine, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249203, India 
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 Ruchi Dua  AIIMS  IPD division, LEVEL 5, Ward procedure room, Pulmonary Medicine Ward, All India Institute of Medical Sciences Virbhadra Road, Rishikesh Uttarakhand- 249203, India
Dehradun
UTTARANCHAL 
7895973469

ruchi.pulm@aiimsrishikesh.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Rishikesh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J939||Pneumothorax, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Clamping group  The chest tube will be clamped for 6 hours, followed by chest radiography. After a successful clamping trial, the ICD will be removed, and the patient will be observed up to 24 hours for recurrence of pneumothorax.  
Comparator Agent  Non-clamping group  The chest tube will be removed after chest radiography shows the resolution of pneumothorax without clamping. A repeat chest radiograph will be taken 24 hours of post chest tube removal.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Diagnosis of “pneumothorax”, planned for ICD removal (There is full lung re-expansion and cessation of air leak) 
 
ExclusionCriteria 
Details  Patients with significant hydropneumothorax/pyopneumothorax/haemothorax
Bilateral pneumothorax
Trapped lung
Patients who were on invasive mechanical ventilation at the time of tube removal 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of proportion of patients undergoing Ipsilateral invasive pleural drainage procedure up to 24 hours of chest drain removal between groups A and B.  24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the proportion of patients detected with occult air leak by clamping prior to ICD removal.  6 hours 
Comparison of the proportion of patients developing pneumothorax up to 24 hours of ICD removal in groups A and B.  24 hours 
Comparison of the proportion of patients with complications in both groups  24 hours 
Comparison of the median duration of hospital stay amongst two groups.  Till discharge 
 
Target Sample Size   Total Sample Size="138"
Sample Size from India="138" 
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)   02/10/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
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 - NO
Brief Summary  

While intercostal chest drain insertion remains a cornerstone in pneumothorax management, the optimal approach for subsequent management post-drain removal remains a subject of debate. Specifically, the decision between clamping the chest drain before removal versus non-clamping lacks consensus and is often guided by individual clinician preference rather than empirical evidence.

This thesis addresses this gap by comparing ipsilateral invasive pleural drainage procedures following Intercostal Chest Drain (ICD) removal in pneumothorax patients. The study will adopt a randomized controlled trial (RCT) design to compare the efficacy, safety, and clinical outcomes of clamped and non-clamped approaches. By rigorously evaluating these two management strategies, this research seeks to provide valuable insights into the optimal post-drain removal management protocol for pneumothorax patients.

Research Hypothesis: Clamping the intercostal drain before removal is non-inferior to not clamping the drain in terms of the need for subsequent ipsilateral invasive pleural drainage in pneumothorax patients.


 
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