| 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
|
|
|
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
|
|
|
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 “pneumothoraxâ€, 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.
|