Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.

Cambridge University Hospitals NHS Foundation Trust1 site in 1 country50 target enrollmentSeptember 15, 2020

ConditionsDysphagia Dysphonia Subglottic Stenosis Voice Disorders Swallowing Disorder Covid19 SARS (Severe Acute Respiratory Syndrome)SARS Pneumonia Quality of Life SARS-CoV-2 Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dysphagia
Sponsor: Cambridge University Hospitals NHS Foundation Trust
Enrollment: 50
Locations: 1
Primary Endpoint: Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study examines the presence, severity and natural history of dysphagia and dysphonia in the post-extubation and severely unwell COVID-19 patient.

Registry

clinicaltrials.gov

Start Date

September 15, 2020

End Date

January 30, 2023

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Responsible Party

Principal Investigator

Ekpemi Irune

Consultant Otolaryngology, Head & Neck Surgeon.

Cambridge University Hospitals NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

•Patients who have been diagnosed with a positive SARS CoV-2 test.
•Patients who have been diagnosed with dysphonia and/or dysphagia following COVID 19 treatment.
•Patients who require investigation and management for dysphonia and/or dysphagia following COVID 19 treatment.
•Adult patients aged 18 years - 85 years.
•Patients that meet threshold for referral to the joint MDT clinic following screening

Exclusion Criteria

•Patients who cannot undertake the assessment for dysphonia and/or dysphagia.
•Patients who are being managed with palliative intent.
•Patients with pre-existing dysphonia and/or dysphagia not previously responding to therapy (pre-existing prior to COVID-19 diagnosis).

Outcomes

Primary Outcomes

Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).

Time Frame: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).

Based on therapy outcome measures from FEES, VoiS

Secondary Outcomes

The severity of dysphonia and/or dysphagia over an initial 12 month period (at t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months)(t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months)
Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation(t = day 0 and 9 months)
The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.(t = day 5, day 10, day 14, day 21 - For in-patients only.)
Relationship between severity of dysphonia and/or dysphagia with grade of ARDS(t = day 0 and 9 months)
Relationship between severity of dysphonia and/or dysphagia with length of intubation(t = day 0 and 9 months)
Relationship between severity of dysphonia on quality of life using Voice Symptom Scale (VoiSS) questionnaire over time at day 0, 1 month and 9 months.(t = day 0, 1 month and 9 months.)
Relationship between severity of dysphagia on quality of life using Dysphagia Handicap Index (DHI) questionnaire over time at day 0, 1 month and 9 months(t = day 0, 1 month and 9 months)