CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 605 enrolled
Drug / intervention
Swallowing evaluation with the EAT-10 and the volume-viscosity swallowing test (V-VST)other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04346212
NCT04346212N/ACompleted

Oropharyngeal Dysphagia and Malnutrition in Patients Infected by SARS-CoV-2: Prevalence and Needs of Compensatory Treatment and Follow up in Patients Admitted by COVID-19 at the Consorci Sanitari Del Maresme

Hospital de Mataró·observational·Posted Apr 15, 2020·Updated Jul 14, 2022

In Brief

An observational study evaluating Swallowing evaluation with the EAT-10 and the volume-viscosity swallowing test (V-VST) for Oropharyngeal Dysphagia and 3 related conditions. Completed, enrolled 605 participants across 1 site.

Detailed Summary

Background: Oropharyngeal dysphagia (OD) is a common complication in/post ICU patients that have been with intubation/mechanical ventilation or with tracheotomies or NG tubes, in patients with acute respiratory infection/pneumonia/respiratory insufficiency with a severe disease needing high concentration of oxygen or noninvasive mechanical ventilation and also in patients discharged from acute hospitals to rehabilitation centers, nursing homes or other facilities. All these situations are common for COVID-19 patients that are currently filling our hospitals due to the pandemic expansion of SARS-CoV-2. OD is associated to prolonged hospitalization, dehydration and severe nutritional and respiratory complications -aspiration pneumonia-, hospital readmissions and mortality. Aim: to assess the prevalence of OD and nutritional risk in these patients and to know their needs of compensatory treatment following the application of an early intervention, and to assess whether OD and malnutrition are indicators of poor prognosis for COVID-19 patients. Methods: prospective study in which we will use the volume-viscosity swallowing test (V-VST) to assess the prevalence of OD, and NRS2002 to assess the nutritional risk in admitted patients with confirmed COVID-19 at the Consorci Sanitari del Maresme, Catalonia, Spain. We will register also results of the EAT-10, nutritional status, the needs of compensatory treatments of these patients following an early intervention with fluid and nutritional adaptation and use of nutritional supplements. We will also collect other clinical variables from medical history of the patient related to hospitalization and we will follow the clinical complications and nutritional status at 3 and 6 months follow up.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 15, 2020
Enrollment StartApr 14, 2020
Primary CompletionSep 30, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 6.2 years ago

Interventions

Swallowing evaluation with the EAT-10 and the volume-viscosity swallowing test (V-VST)other

We will assess dysphagia, nutritional status and needs of compensatory treatment (fluid and nutritional adaptation) in patients with COVID-19 disease. We will also collect clinical data, information about swallowing and nutritional status and needs through the electronical medical history of the patients and by telephone call at 3 and 6 months follow-up, as well as clinical complications.