| CTRI Number |
CTRI/2024/03/063425 [Registered on: 01/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study among the Ear Nose and Throat surgeons to look for their practices and outcomes
in removing the temporary tube inserted in the patients wind pipe |
|
Scientific Title of Study
|
Tracheostomy decannulation practices among ENT surgeons and the observed outcomes - a cross sectional 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 |
Anjali George |
| Designation |
Assistant Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of ENT
Jubilee Mission Medical College and Research Institute,
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
04872432200 |
| Fax |
|
| Email |
anjalicherish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anjali George |
| Designation |
Assistant Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of ENT
Jubilee Mission Medical College and Research Institute,
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
04872432200 |
| Fax |
|
| Email |
anjalicherish@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali George |
| Designation |
Assistant Professor |
| Affiliation |
Jubilee Mission Medical College and Research Institute |
| Address |
Department of ENT
Jubilee Mission Medical College and Research Institute,
Thrissur
Thrissur
KERALA
680005
India |
| Phone |
04872432200 |
| Fax |
|
| Email |
anjalicherish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jubilee Mission Medical College and Research Institute
Thrissur
Kerala
India
680005 |
|
|
Primary Sponsor
|
| Name |
Jubilee Mission Medical College Research Institute |
| Address |
East Fort
Thrissur, Kerala, India
680005 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jubilee Mission Medical College Research Institute |
East Fort,
Thrissur,
Kerala,
India
680005 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anjali George |
Jubilee Mission Medical College and Research Institute |
Department of ENT,
First Floor,
St Thomas block,
Jubilee Mission Medical College and Research Institute
East Fort
Thrissur
KERALA |
04872432200
anjalicherish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Jubilee Mission Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Survey among ENT consultants |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Tracheotomy done for a reversible condition and decannulation expected.
Tracheostomy done by an experienced consultant who does more than 10 tracheostomies a year.
|
|
| ExclusionCriteria |
| Details |
Pregnant patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the success rate between decannulation techniques with and without metal tubes. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Whether there is any difference in the duration from decision to decannulation between the different techniques |
12 months |
|
|
Target Sample Size
|
Total Sample Size="352"
Sample Size from India="352"
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)
|
14/03/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Tracheostomy is an airway procedure commonly performed by surgeons and intensivists. The duration for which the patient is maintained on a tracheostomy tube can vary depending on the primary indication for the procedure. There are no universal guidelines available for tracheostomy decannulation. Our study is aimed at evaluating the different decannulation techniques followed by the ENT surgeons and the outcomes of the same. |