| CTRI Number |
CTRI/2021/11/037756 [Registered on: 02/11/2021] Trial Registered Prospectively |
| Last Modified On: |
30/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A clinical trail to evaluate the survival rate and quality of life in tracheostomised patients. |
|
Scientific Title of Study
|
Tracheostomy after surgery: an assessment of
predictors, complications and patient outcome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| IEC-AIMS-2021-ANES-197 Dated 30-07-2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fayas Mohammed M |
| Designation |
Msc Respiratory therapy student |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
Department of Anesthesiology
Amrita Institute of Medical Sciences
Kochi
Kerala
Kochi
kerala
682041
Ernakulam
KERALA
682041
India |
| Phone |
9003686731 |
| Fax |
|
| Email |
fayasmohammed1098@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopan G |
| Designation |
assistant professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
8547242555
gopangp@aims.amrita.edu
Department of Cardiac Anesthesiology
Amrita Institute of Medical Sciences
Kochi
682041
Ernakulam
KERALA
682041
India |
| Phone |
8547242555 |
| Fax |
|
| Email |
gopangp@aims.amrita.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gopan G |
| Designation |
assistant professor |
| Affiliation |
Amrita Institute of Medical Sciences |
| Address |
8547242555
gopangp@aims.amrita.edu
Department of Cardiac Anesthesiology
Amrita Institute of Medical Sciences
Kochi
682041
Ernakulam
KERALA
682041
India |
| Phone |
8547242555 |
| Fax |
|
| Email |
gopangp@aims.amrita.edu |
|
|
Source of Monetary or Material Support
|
| Since it is an observational study no material or monetary support required |
|
|
Primary Sponsor
|
| Name |
Fayas Mohammed M |
| Address |
Division of Respiratory Therapy
Department of Anesthesiology
Amrita Institute of Medical Sciences
Kochi
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Fayas Mohammed M |
Amrita Institute of Medical Sciences |
Divisions of Orthopedic, Neurologic, Head and Neck , Cardiovascular and Thoracic surgical units
Department of Anaesthesiology
Ernakulam
KERALA |
9003686731
fayasmohammed1098@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee – Amrita Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing tracheostomy after surgery. |
|
| ExclusionCriteria |
| Details |
1.Brain dead patients
2.Patients with tracheostomy before the surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To understand the survival rate of tracheostomized patients after surgery |
1 month, 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Predict the risk factor for mortality in post-operative tracheostomy
2. To review the techniques used for tracheostomies in ICU
3. To know the in-hospital complications due to tracheostomy
4. To know the chances and rate of decannulation after tracheostomy
|
1 month, 3rd month and 6th month |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
15/11/2021 |
| 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
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an observational trial to assess the predictors, complications and outcomes of tracheostomized patients after surgery . The primary objective is to understand the survival rate of tracheostomized patients after surgery. The secondary outcome measures include predicting the risk factors for mortality; to review the technique used for the tracheostomies; to know the in-hospital complications and to know the chances of rate of decannulation after tracheostomy. |