| CTRI Number |
CTRI/2026/01/101556 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Checking Swallowing Safety in Heart Surgery Patients After Breathing Tube Removal Using a Small Camera Test Fibreoptic Endoscopic Evaluation of Swallowing (FEES) |
|
Scientific Title of Study
|
Fibreoptic Endoscopic Evaluation of Swallowing (FEES) In Cardiac surgical Patients post extubation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Reddy |
| Designation |
Consultant Department of Anesthesiology |
| Affiliation |
Fortis Hospital |
| Address |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
8105840754 |
| Fax |
|
| Email |
rakesh.doctor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Reddy |
| Designation |
Consultant Department of Anesthesiology |
| Affiliation |
Fortis Hospital |
| Address |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
8105840754 |
| Fax |
|
| Email |
rakesh.doctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Reddy |
| Designation |
Consultant Department of Anesthesiology |
| Affiliation |
Fortis Hospital |
| Address |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
8105840754 |
| Fax |
|
| Email |
rakesh.doctor@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Academic Investigator Initiated Project |
| Address |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore 560076 |
| 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 |
| Dr Rakesh Reddy |
Fortis Hospital |
Department of Anesthesia
Fortis Hospitals limited 154 Bannerghatta Road Opp IIMB Bangalore
Bangalore
KARNATAKA |
8105840754
rakesh.doctor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| FORTIS HOSPITAL INSTITUTIONAL ETHICS COMMITTEE |
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
|
| Type |
Name |
Details |
| Intervention |
Fibreoptic Endoscopic Evaluation of Swallowing |
Fibreoptic Endoscopic Total Duration over 15 minutes |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
98.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients age greater than or equal to 18 years who have been mechanically ventilated for at least 12 hours and are undergoing extubation in the Intensive care unit.
2.Patients in whom transoesophageal echocardiography was required.
3.Patients who are clinically stable and able to tolerate the procedure in terms of vital signs and alertness.
4.Patients who are willing to participate and provide consent
|
|
| ExclusionCriteria |
| Details |
1.Severe neurological impairments e.g. Recent stroke or significant cognitive impairment.
2.Uncooperative or non-alert patients who are unable to follow basic commands.
3.Recent upper respiratory tract infection or anatomical obstruction in the upper airway.
4.Patients with severe nasal or facial trauma
5.Patients with significant bleeding disorder
6.Patients requiring reintubation during the study period.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of Penetration and Aspiration post extubation in cardiac surgical patients |
At the end of study duration data will be collected study duration 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify patients who are at high risk of aspiration and advise appropriate therapeutic interventions. |
At the end of study duration data will be collected study duration 12 months |
|
|
Target Sample Size
|
Total Sample Size="131"
Sample Size from India="131"
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)
|
03/02/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Swallowing dysfunction and pulmonary
aspiration often occur in patients who receive prolonged mechanical
ventilation. Several studies have shown a
significant association between dysphagia and aspiration pneumonia. Mechanism for aspiration pneumonia
include disuse atrophy of muscles during intubation, suppression of cough
reflexes, inconsistent triggering of swallowing reflex, diminished
proprioception, and residual effect of sedatives. The prevalence of swallowing
dysfunction post-extubation has been reported to occur in 20 and 83% of those
patients intubated longer than 48 hrs. Fibreoptic Endoscopic
Evaluation of Swallowing FEES is a diagnostic procedure that
involves the use of a flexible endoscope to assess the anatomy and physiology
of swallowing. |