| 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
|
|
|
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
|
|
|
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. |