| CTRI Number |
CTRI/2012/09/002971 [Registered on: 06/09/2012] Trial Registered Retrospectively |
| Last Modified On: |
06/09/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective Observational s |
| Study Design |
Other |
|
Public Title of Study
|
A study to retrospectively compare success and outcomes of percutaneous dilatational tracheostomy done using two different techniques |
|
Scientific Title of Study
|
A retrospective observational study of percutaneous dilational tracheostomy under real time ultrasound guidance |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jose Chacko |
| Designation |
Consultant, Critical Care |
| Affiliation |
Manipal Hospital |
| Address |
Multidisciplinary Intensive Care Unit, Manipal Hospital, Bangalore 560017
Bangalore
KARNATAKA
560102
India |
| Phone |
09844143041 |
| Fax |
09844143041 |
| Email |
chackojose@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jose Chacko |
| Designation |
|
| Affiliation |
Manipal Hospital |
| Address |
Multidisciplinary Intensive Care Unit, Manipal Hospital, Bangalore 560017
Bangalore
KARNATAKA
560102
India |
| Phone |
09844143041 |
| Fax |
09844143041 |
| Email |
chackojose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jose Chacko |
| Designation |
|
| Affiliation |
Manipal Hospital |
| Address |
Multidisciplinary Intensive Care Unit, Manipal Hospital, Bangalore 560017
Bangalore
KARNATAKA
560102
India |
| Phone |
09844143041 |
| Fax |
09844143041 |
| Email |
chackojose@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Manipal Hospital Bangalore |
| Address |
Manipal Hospital
HAL Airport Road
Bangalore 560017 |
| 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 |
| Jose Chacko |
Multidisciplinary Intensive Care Unit, Manipal Hospital, Bangalore |
HAL Airport Road
Bangalore
PIN 560017
Bangalore
KARNATAKA |
9844143041
chackojose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manipal Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Mechanically ventilated patients in the Intensive Care Unit, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing mechanical ventilation for more than 2 days in the ICU |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Success of tracheostomy
Complications of tracheostomy |
Success of tracheostomy
Complications of tracheostomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time taken to do the procedure |
1 day |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
01/01/2012 |
| 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) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
We intend to retrospectively compare success and outcomes of percutaneous dilatational tracheostomy done using two different techniques:
1. Using real time ultrasound guidance and bronchoscopy
Versus
2. Real time ultrasound guidance alone |