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CTRI Number  CTRI/2025/08/093573 [Registered on: 25/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative analysis of applying negative pressure to pleural suction through intercostal drainage tube versus not applying negative pressure for intercostal drainage tube to analyze duration of intercostal tube drainage 
Scientific Title of Study   Comparative Analysis of Initial Negative Pressure Pleural Suction Followed by Underwater Seal Drainage Versus Continuous Underwater Seal Drainage in Thoracic Trauma Patients: Impacts on ICD Duration, Hospital Stay, and Complication Rates 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karthik Kotari 
Designation  junior resident 
Affiliation  AIIMS patna 
Address  ROOM no 204 department of trauma surgery AIIMS patna phulwarisharif patna bihar

Patna
BIHAR
801507
India 
Phone  9632191728  
Fax    
Email  karthikkotari093@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anurag Kumar 
Designation  Associate professor  
Affiliation  AIIMS patna 
Address  room no 204 department of trauma surgeryAIIMS patna phulwarisharif patna bihar

Patna
BIHAR
801507
India 
Phone  8340267114  
Fax    
Email  dranuragguddu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Karthik Kotari 
Designation  junior resident 
Affiliation  AIIMS patna 
Address  room no 204 department of trauma surgery AIIMS patna phulwarisharif patna bihar

Patna
BIHAR
801507
India 
Phone  9632191728  
Fax    
Email  karthikkotari093@gmail.com  
 
Source of Monetary or Material Support  
Room no 107 department of trauma surgery aiims patna phulwarisharif patna India pincode 801507 
 
Primary Sponsor  
Name  NIL 
Address  nil 
Type of Sponsor  Other [nil] 
 
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 Karthik Kotari  AIIMS PATNA  Room no. 204 Department of trauma surgery AIIMS PATNA
Patna
BIHAR 
96321 91728

karthikkotari093@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMSPATNA INSTITUTIONAL ETHICAL COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inercostal drainage tube insertion with negative pressure suction application  Duration of intervention 7 days 
Comparator Agent  Intercostal drainage tube without negative suction  Intervention for 7 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients with blunt trauma chest requiring ICD insertion
ICD inserted and negative pressure applied to test group and not applied in 2nd group 
 
ExclusionCriteria 
Details  Pre-existing Conditions: Chronic pulmonary diseases (COPD ,Lung fibrosis, Emphysema)
Mechanical Support: Need for mechanical ventilator support.
Prior Treatment: Referred patients with ICDs already placed in previous hospitals.
Those who does not give consent for ICD.
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The study anticipates that initial negative pressure pleural suction followed by underwater seal drainage will reduce ICD duration, hospital stay, and complication rates compared to continuous underwater seal drainage in thoracic trauma patients.  1 week 
 
Secondary Outcome  
Outcome  TimePoints 
Initial negative pressure reduces the duration & complications of ICD  1 week 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 2 
Date of First Enrollment (India)   02/09/2025 
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="0"
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 - NO
Brief Summary  

This study aims to compare the effectiveness of Initial Negative Pressure Pleural Suction Followed by Underwater Seal Drainage with Continuous Underwater Seal Drainage in patients requiring pleural drainage for pleural effusions or pneumothorax. The research will be conducted as a randomized controlled trial, enrolling adult patients who meet the inclusion criteria. After obtaining informed consent, participants will be randomly assigned to one of two groups: the Initial Negative Pressure Pleural Suction group or the Continuous Underwater Seal Drainage group. In the Initial Negative Pressure group, patients will first receive pleural suction using negative pressure to swiftly evacuate air or fluid from the pleural cavity. Following this initial suction phase, an underwater seal drainage system will be employed to continuously manage and monitor pleural drainage. Conversely, participants in the Continuous Underwater Seal Drainage group will have a chest drain inserted and connected directly to an underwater seal drainage system from the beginning, avoiding the initial negative pressure phase. Both groups will be closely monitored for clinical outcomes with Regular chest X-rays which will be conducted to assess the resolution of the pleural condition and to ensure appropriate tube placement. Data collection will include metrics on drainage duration, length of hospital stay, and patient-reported comfort and satisfaction. Statistical analysis will compare the primary outcomes—time to resolution of the pleural issue and rates of complications—between the two drainage methods. The study will adhere to ethical standards, receiving approval from the relevant institutional review board, and ensuring informed consent from all participants. Follow-up will extend for at least 7 days or until clinical resolution, providing a thorough evaluation of both drainage strategies.

 
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