| CTRI Number |
CTRI/2012/12/003224 [Registered on: 17/12/2012] Trial Registered Prospectively |
| Last Modified On: |
16/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective cohort study |
| Study Design |
Other |
|
Public Title of Study
|
Experience with Bedside Surgical procedure of creating an opening in the Windpipe at an Adult Intensive care unit in Tertiary Hospital of Northern India |
|
Scientific Title of Study
|
Experience with Percutaneous Tracheostomy at an adult intensive care institute in northern India:
A descriptive study
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Version 1.0 dated 20th Sept,2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrYatin Mehta |
| Designation |
Chairman Crtical care and Anesthesia |
| Affiliation |
Medanta-The Medicity |
| Address |
Medanta-The Medicity
Sec-38,Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
yatin.mehta@medanta.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChitra Mehta |
| Designation |
Senior Consultant |
| Affiliation |
Medanta-The Medicity |
| Address |
Medanta-The Medicity
Sec-38,Gurgaon
Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
mehtachitra@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChitra Mehta |
| Designation |
Senior Consultant |
| Affiliation |
Medanta-The Medicity |
| Address |
Medanta-The Medicity
Sec-38,Gurgaon
HARYANA
122001
India |
| Phone |
|
| Fax |
|
| Email |
mehtachitra@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta-The Medicity Sec-38,Gurgaon,India |
|
|
Primary Sponsor
|
| Name |
MedantaThe Medicity |
| Address |
Sec-38,Gurgaon,Haryana |
| 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 |
| DrYatin Mehta |
Medanta Institute of Critical care and Anesthesia |
Medanta Institute of Critical care and Anaesthesia,1st Floor,Medanta-The Medicity
Gurgaon
HARYANA |
9971698149
yatin.mehta@medanta.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Independent Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All patients who underwent percutaneous tracheostomy in Intensive care unit, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patient above 18years of age and those who underwent percutaneous tracheostomy in Intensive care units between November,2009 and June 2012 are enrolled.
|
|
| ExclusionCriteria |
| Details |
Patient leaving against medical advise soon after percutaneous tracheostomy
Patient shifted to outside ICU soon after percutaneous tracheostomy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative, immediate (upto 8 hrs.) & short term (8-24 hrs) major & minor complications |
34 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of ICU stay and mortality |
34 months |
|
|
Target Sample Size
|
Total Sample Size="800"
Sample Size from India="800"
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)
|
20/12/2012 |
| 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="2"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study will enable us to assess the incidence of early complications of percutaneous tracheostomy and provide data which can be used for future studies, The study will also explore optimum timing & technique of percutaneous dilational tracheostomy for specific patients |