Clinical trial NCT04584658: Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)
Official title: Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dysphagia
Dysphonia
Subglottic Stenosis
Voice Disorders
Swallowing Disorder
Covid19
SARS (Severe Acute Respiratory Syndrome)
SARS Pneumonia
Quality of Life
SARS-CoV-2 Infection
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-10-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients identified with dysphagia and dysphonia secondary to COVID19 infection. Specifically severely unwell patients and post-extubation patients.

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.


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).

Primary outcomes:
measure: 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).
timeFrame: t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
Secondary outcomes:
measure: 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)
timeFrame: t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months
measure: The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.
timeFrame: t = day 5, day 10, day 14, day 21 - For in-patients only.
measure: Relationship between severity of dysphonia and/or dysphagia with grade of ARDS
timeFrame: t = day 0 and 9 months
measure: Relationship between severity of dysphonia and/or dysphagia with length of intubation
timeFrame: t = day 0 and 9 months
measure: Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation
timeFrame: t = day 0 and 9 months
measure: 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.
timeFrame: t = day 0, 1 month and 9 months.
measure: 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
timeFrame: t = day 0, 1 month and 9 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
Study officials:
References: