| CTRI Number |
CTRI/2024/03/064886 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The effect of low pressure negative suction machine on chest tubes inserted in chest trauma patients instead of simply underwater seal bottle application for faster recovery from hemopneumothorax, hemothorax and pneumothorax |
|
Scientific Title of Study
|
The impact of low pressure negative pleural suction versus underwater seal drainage in patient of thoracic trauma: A randomised controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shahnawaz Ahmad |
| Designation |
Junior Resident |
| Affiliation |
King George Medical University, Lucknow India |
| Address |
Room no:- 304, New TG hostel, Khadra, King George Medical University, Lucknow, Uttar Pradesh, India
8th floor, stabadi phase II,Department of trauma surgery, KGMU, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9097443642 |
| Fax |
|
| Email |
sahmadforu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Jaiswal |
| Designation |
Additional professor |
| Affiliation |
King George Medical University, Lucknow |
| Address |
8th floor, Department of trauma surgery , stabadi phase II, KGMU, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
919935440642 |
| Fax |
|
| Email |
vaibhavjaiswal@kgmcindia.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Jaiswal |
| Designation |
Additional professor |
| Affiliation |
King George Medical University, Lucknow |
| Address |
Department of trauma surgery, 8th floor, stabadi phase II, KGMU, Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
919935440642 |
| Fax |
|
| Email |
vaibhavjaiswal@kgmcindia.edu |
|
|
Source of Monetary or Material Support
|
| King Georges Medical University, Lucknow, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
King George Medical University, Lucknow |
| Address |
Department of trauma surgery, 8th floor, stabadi phase II, KGMU, Lucknow |
| 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 Shahnawaz Ahmad |
King Georges Medical University, Lucknow, Uttar Pradesh, India |
First floor, trauma surgery ward (TSW), trauma centre.
Lucknow
UTTAR PRADESH |
9097443642
sahmadforu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| King Georges Medical University, U. P, institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: S272||Traumatic hemopneumothorax, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Low pressure negative pleural suction |
During the study, Group 1 patients will be connected to a -20 cm H2O continuous negative suction system, which was interrupted only by the change of system or the movement of the patient to the bathroom. Study will be conducted for 18 months. |
| Comparator Agent |
Underwater seal drainage |
During the study, Group 2 patients will be connected underwater seal drainage , which was interrupted only by the change of system or the movement of the patient to the bathroom. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. All patients more than 15 years of age.
2. Patients who diagnosed with traumatic
pneumothorax, hemothorax or
hemopneumothorax (penetrating or blunt)
will be enrolled. |
|
| ExclusionCriteria |
| Details |
1. Not giving consent
2. Patients with history of pulmonary
diseases or heart failure chronic
pulmonary diseases (chronic obstructive
pulmonary disease, diffuse interstitial
lung disease)
3. Active tuberculosis
4. Patients with multiple injuries with
severe traumatic brain injury (TBI) and
Glasgow Coma Scale score less than 8 of
15
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish the benefits of chest tube use with negative pleural suction compared with the underwater seal drainage system in patients with thoracic trauma. |
Outcomes will be accessed clinically and radiologically every 24 hourly. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To study the incidence of complications, such as persistent air leak, coagulated hemothorax, empyema, recurrent pneumothorax.
2.To study the length of hospitalization
3.To study the need for additional surgeries (new chest tube, thoracostomy, or thoracotomy).
|
Outcomes will be accessed every 24 hourly
|
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
04/04/2024 |
| 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="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Thoracic trauma affects approximately 60% of patients with multiple injuries and is responsible for 20% to 25% of trauma-related deaths. Types of thoracic trauma:- 1. hemopneumothorax (52.3%), most common 2. hemothorax (23.4%) and 3. pneumothorax (20-20.7%) For most of the patients of thoracic trauma requires only the placement of a chest tube connected to a underwater seal drainage system Downside of ICD:- despite of ICD, complication such as persistent air leak, clotted hemothorax, and empyema. These complications increase morbidity, the need for more complex surgeries, hospital stay, and health-related costs. Low pressure negative pleural suction:- For inducing pleural attachment and promoting the quick closing of air leaks and hemothorax drainage.
|