Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study)

Covid19 Clinical Trial

— DYADS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584658
• Other study ID #: 20/NW/0333
• Status: Recruiting
• Start date: September 15, 2020
• Est. completion date: December 2021

Study information

• Verified date: December 2020
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19
• Deglutition Disorders
• Disease
• Dysphagia
• Dysphonia
• Hoarseness
• Infection
• Quality of Life
• SARS (Severe Acute Respiratory Syndrome)
• SARS Pneumonia
• SARS-CoV-2 Infection
• Severe Acute Respiratory Syndrome
• Subglottic Stenosis
• Swallowing Disorder
• Voice Disorders

Intervention

Diagnostic Test:
• Fibreoptic Endoscopic Evaluation of Swallowing (FEES)
This is the use of endoscopy during feeding trials. The patient is fed different consistencies of food and drink while an endoscope is in place (usually passed through the nasal passage and down into the throat). The endoscope provides a bird's eye view to the transit of food through the upper aero-digestive tract. This provides information from the point of food bolus formation in the mouth to the movement of the base of the tongue; the movement of pharyngeal muscles; the deflection of the epiglottis to protect the airway including the closure of the vocal cords and the passage of food into the oesophagus. Any abnormality in these steps are noted during FEES. Liquids, thickened fluids, semi-solids and solids are some of the food textures that are tested.
• Videofluoroscopy
A radio opaque dye is used to label the test food and drink items offered to the patient. Following this, x-ray technology is used to create a video of the outline of the patient and the structures responsible for chewing and swallowing as they injest the test materials. The study is carried out in real time in the radiology department in conjunction with a radiographer and an SLT.

Other:
• Dysphagia Handicap Index (DHI)
This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).
• Voice Symptom Scale (VoiSS)
This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28.

Locations

Country	Name	City	State
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge

Sponsors (1)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Based on therapy outcome measures from FEES, VoiS	t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation).
Secondary	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)	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy	t = 14 days, 1 month, 3 months, 6 months, 9 months, 12 months
Secondary	The severity of dysphonia and/or dysphagia at t = day 5, day 10, day 14, day 21 - For in-patients only.	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy	t = day 5, day 10, day 14, day 21 - For in-patients only.
Secondary	Relationship between severity of dysphonia and/or dysphagia with grade of ARDS	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy	t = day 0 and 9 months
Secondary	Relationship between severity of dysphonia and/or dysphagia with length of intubation	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy	t = day 0 and 9 months
Secondary	Relationship between severity of dysphonia and/or dysphagia with duration of mechanical ventilation	Clinical assessment including outcome measures, FEES and/or Videofluoroscopy	t = day 0 and 9 months
Secondary	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.	Questionnaire assessment: This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28	t = day 0, 1 month and 9 months.
Secondary	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	Questionnaire assessment: This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).	t = day 0, 1 month and 9 months