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Validation of a tool to evaluate swallowing difficulty in individuals with tracheostomy

Validation of protocol for assessing dysphagia in individuals with tracheostomy

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020359
Enrollment
41
Registered
2019-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z930- Tracheostomy status

Interventions

Intervention1: NOT APPLICABLE: NOT APPLICABLE Intervention2: Protocol for assessing dysphagia in individuals with tracheostomy: Screening for swallowing which is considered to be robust but minimally

Sponsors

Ragi Rajan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Individuals with dysphagia post tracheostomy Age range between 18 â?? 70 years Able to sit upright/semi upright posture Individuals who are referred for FEES evaluation and given consent will be enrolled in the study

Exclusion criteria

Exclusion criteria: Individuals who are unable to follow the commands Individuals with carcinomas, glossectomy

Design outcomes

Primary

MeasureTime frame
The Demographic and Clinical variables will be noted. The Level of Agreement will be obtained using Bland - Altman plot between the protocol and the FEES. Pearson correlation coefficient will be used to determine the correlation between the protocol and the FEES.Timepoint: Data collection and data analysis from June 2019 - March 2020

Secondary

MeasureTime frame
NOT APPLICABLETimepoint: NOT APPLICABLE

Countries

India

Contacts

Public ContactRagi Rajan

Manipal College of Health Professions

deepa.n@manipal.edu9986447191

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026