| CTRI Number |
CTRI/2021/10/037248 [Registered on: 11/10/2021] Trial Registered Prospectively |
| Last Modified On: |
06/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Audit |
| Study Design |
Other |
|
Public Title of Study
|
AUDIT ON CHEST DRAIN INSERTION |
|
Scientific Title of Study
|
AN AUDIT ON CHEST DRAIN INSERTION |
| Trial Acronym |
CDI |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pavankumar velagambeti |
| Designation |
Pg student |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44,54,4th T-block east, General surgery department, Ground floor, Room no 10, Tilak nagar main road, Bannerughatta approach road layout, Jayanagar
Bangalore
KARNATAKA
560041
India |
| Phone |
08790350665 |
| Fax |
|
| Email |
velagambetipavan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavankumar velagambeti |
| Designation |
Pg student |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44,54,4th T-block east, General surgery department, Ground floor, Room no 10, Tilak nagar main road, Bannerughatta approach road layout, Jayanagar
Bangalore
KARNATAKA
560041
India |
| Phone |
08790350665 |
| Fax |
|
| Email |
velagambetipavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pavankumar velagambeti |
| Designation |
Pg student |
| Affiliation |
SAGAR HOSPITALS |
| Address |
44,54,4th T-block east, General surgery department, Ground floor, Room no 10, Tilak nagar main road, Bannerughatta approach road layout, Jayanagar
Bangalore
KARNATAKA
560041
India |
| Phone |
08790350665 |
| Fax |
|
| Email |
velagambetipavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| SAGAR HOSPITALS, BANGALORE |
|
|
Primary Sponsor
|
| Name |
SAGAR HOSPITALS |
| Address |
44,54,4th T-block east, General surgery department, Ground floor, Room no 10, Tilak nagar main road, Bannerughatta approach road layout, Jayanagar |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Rajashekara Reddy |
Sagar Hospitals |
44,54,4th T-block east, General surgery department, Ground floor, Room no 10, Tilak nagar main road, Bannerughatta approach road layout, Jayanagar
Bangalore
KARNATAKA |
9880005774
reddyvats@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J984||Other disorders of lung, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients who underwent ICD insertion in ICU or in emergency department |
|
| ExclusionCriteria |
| Details |
ICD inserted in OT following thoracic procedure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Confirmas to set guidelines |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To know chest drain related complication |
1year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/10/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
ATLS chest drain insertion and management of chest drain |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Chest drain insertion is a life saving procedure for majority of patients, so this essential skill should be attained by every resident – Acute Trauma Life Support 2. It allows drainage of air (pneumothorax), blood (haemothorax), fluid (pleural effusion) or pus (empyema) out of the chest 3. Allows drainage of the pleural contents and re-expansion of the lung 4. In case of pneumothorax or haemothorax, this helps to restore haemodynamic & respiratory stability |