| CTRI Number |
CTRI/2023/12/060467 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
01/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Classification of high risk tracheostomy patients on mechanical ventilation |
|
Scientific Title of Study
|
Risk stratification of tracheostomised patients on mechanical ventilation |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prithvi Jaishankar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of ENT- Head and neck surgery, ENT OPD- 4th floor, Room number 13, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8610588723 |
| Fax |
|
| Email |
jprithvi97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suresh Pillai |
| Designation |
MBBS, DLO, DNB |
| Affiliation |
Kasturba medical college,Manipal |
| Address |
Professor, Department of ENT- Head and neck surgery, Kasturba Medical College, 4th floor ENT OPD, Manipal 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9901728977 |
| Fax |
|
| Email |
surpil21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prithvi Jaishankar |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, MAHE, Manipal |
| Address |
Department of ENT- Head and neck surgery, ENT OPD 4th floor, room number 13, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8610588723 |
| Fax |
|
| Email |
jprithvi97@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
Kasturba medical college,manipal,576104 |
| Type of Sponsor |
Private medical college |
|
|
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 Prithvi Jaishankar |
Kasturba medical college, manipal |
Department of ENT- Head and neck surgery, ENT OPD 4TH floor, room number 13, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
8610588723
jprithvi97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba medical college and kasturba hospital instutional ethics commitee- 2( student research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J950||Tracheostomy complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
- Adults above the age of 18 years |
|
| ExclusionCriteria |
| Details |
- Paediatric age group
- Previously tracheostomised patients |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To have a standardized grading system for various risk classes of tracheostomy based on the identifiable risk factors and attempt to solve the discrepancy of what defines a high risk tracheostomy |
We will be assessing the patient one day before the tracheostomy with the help of the PRIST scoring system & assess the patient intraoperative & also 7 days post the tracheostomy procedure. The assessment will be a total of 9 days to look for any complications during and after the procedure and link it with the risk factors mentioned in our scoring system.At the end of 9 days we will compile all the complications that occured to the patient and will categorize them into high,medium or low risk. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify high risk tracheostomy patients prior to the tracheostomy procedure |
After 9 days of assessing the tracheostomised patient on mechanical ventilation we will categorize the patient based on the complications post the procedure into high, medium & low risk groups with the help of the scoring systems & we will be better prepared to identify high risk patients prior to the tracheostomy & reduce the complications |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
11/12/2023 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is an observational study where we are attempting to classify a high risk tracheostomy for patients in the ICU on mechanical ventilation. After this study we will attempt to classify a high risk tracheostomy and be better prepared for the complications associated with a high risk tracheostomy |