| CTRI Number |
CTRI/2025/02/081332 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Risk factors for dysphagia in elderly patients on ventilator support. |
|
Scientific Title of Study
|
Incidence and risk factors of postextubation dysphagia in mechanically ventilated elderly patients: an observational 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 |
Reena Chakravarty |
| Designation |
senior resident |
| Affiliation |
AIIMS bhubaneswar |
| Address |
AIIMS bhubaneswar,CICU,SICU in 2nd floor ,Emergency building
Khordha
ORISSA
751019
India |
| Phone |
7722939442 |
| Fax |
|
| Email |
5657reena@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reena Chakravarty |
| Designation |
senior resident |
| Affiliation |
AIIMS bhubaneswar |
| Address |
AIIMS bhubaneswar,2nd floor , cicu,sicu ,emergency building
Khordha
ORISSA
751019
India |
| Phone |
7722939442 |
| Fax |
|
| Email |
5657reena@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Reena Chakravarty |
| Designation |
senior resident |
| Affiliation |
AIIMS bhubaneswar |
| Address |
AIIMS bhubaneswar,SICU,CICU,2nd floor,emergency ,building
Khordha
ORISSA
751019
India |
| Phone |
7722939442 |
| Fax |
|
| Email |
5657reena@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS bhubaneswar,odisa,India,PIN- 751019 |
|
|
Primary Sponsor
|
| Name |
reena chakravarty |
| Address |
AIIMS bhubaneswar,odisa,INDIA,751019 |
| Type of Sponsor |
Government 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 reena chakravarty |
AIIMS bhubaneswar |
ANAESTHESIA AND CRITICAL CARE,CRITICAL CARE ,2nd floor ICU
Khordha
ORISSA |
7722939442
5657reena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aiims bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: U072||COVID 19 virus not identified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
elderly population |
|
| ExclusionCriteria |
| Details |
Immediate re-intubation, airway surgery, tracheostomy
Cognitive impairment
Head and neck surgery
Recent oesophageal injury or oesophageal surgery
Known case of severe dysphagia
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dysphagia at 24 hrs of post extubation |
1 day,30 days,90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 90 days outcome in dysphagia |
90 days |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
06/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 observational study for elderly population post extubation dysphagia at 24hrs post extubation.it will be accessed by GUSS-ICU SCORE with three different time period of 3hrs ,6-8hrs and at 24 hrs .by giving different consistency of food . |