| CTRI Number |
CTRI/2023/10/058474 [Registered on: 10/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation of long term sequeale in adult patient with blunt chest trauma managed with chest tube insertion- A monocentric study |
|
Scientific Title of Study
|
Evaluation of Long term sequelae in adults with blunt chest trauma managed with Intercostal tube drainage- A monocentric 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 Sabarish Soundar |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences, Saifai |
| Address |
Dept of General Surgery,
Room No 104, DTH JR Hostel
Uttar Pradesh University of Medical Sciences, Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9787132978 |
| Fax |
|
| Email |
drsabarishsoundar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shailendra Pal Singh |
| Designation |
Senior Professor and Head of the Department |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Dept of General Surgery,
Uttar Pradesh University of Medical Sciences,
Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9457879726 |
| Fax |
|
| Email |
drspsinghsaifai@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabarish Soundar S |
| Designation |
Junior resident |
| Affiliation |
Uttar Pradesh University of Medical Sciences |
| Address |
Dept of General surgery
Room no 104, JR Hostel DTH
UPUMS Saifai, Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9787132978 |
| Fax |
|
| Email |
drsabarishsoundar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical Sciences, Saifai, Etawah |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical sciences |
| Address |
Uttar Pradesh University of Medical sciences,
Saifai,
Etawah,
Uttar Pradesh. |
| 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 Sabarish Soundar S |
Uttar Pradesh University of Medical Science |
Department of General Surgery,
Uttar Pradesh University of Medical Sciences,
Saifai
Etawah
UTTAR PRADESH |
9787132978
drsabarishsoundar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UttarPradesh University of Medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients admitted in Emergency ward, UPUMS Trauma centre with Blunt Chest trauma requiring Intercostal tube drainage
Patient accepting informed and written consent for the study
Patients willing for regular follow up as adviced |
|
| ExclusionCriteria |
| Details |
Penetrating injuries to the chest wall or upper torso
Associated head or abdominopelvic injuries
Paediatric patients <5years of age
Pre-existing Lung diseases and cardiac diseases or illness causing reduced lung volume/lung reserve
Congenital chest wall abnormalities/defects
Pregnancy
Patients with flail chest and/or requiring surgical intervention other than Intercostal tube drainage
Previous history of chest trauma
Patient not giving consent to be the part of study or not willing for follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Late complications in adult patients of blunt chest trauma managed with Intercostal tube drainage
2) Pulmonary function test assessment of adult patient managed with ICD for blunt chest trauma |
1month, 3months and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
No of patients having chronic cough, chest tightedness, chronic sinus discharge from ICD site,
Smoking history
Pulmonary function assessments from PFT
6 min walking test
Presence of pleural calcification, recurrent hemothorax/pneumothorax, rib fractures on chest xray
|
1month, 3months & 6months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/10/2023 |
| 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)
|
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
|
This study aims to evaluate long term complications and pulmonary functions in patients managed with Intercostal tube drainage in regular follow up. It involves observational study single arm with sample size of 100. Inclusion and exclusion criteria as mentioned earlier. Institutional ethical clearance has been obtained to do study. |