Oropharyngeal Dysphagia in Patients With COVID-19

NCT04346212 | Completed DMC

• 1 other identifier: COVID_OD
• Study Type: observational
• Target: 605
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oropharyngeal Dysphagia; COVID-19; Sars-CoV2; Nutrition

Outcome Measures

Primary Outcomes (1)

• Changes in the prevalence of oropharyngeal dysphagia

  Changes in the prevalence of oropharyngeal dysphagia according to a clinical assessment tool, the Volume-Viscosity Swallowing Test (V-VST).

  From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).

Secondary Outcomes (11)

• Changes in the swallowing screening

  From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).

• Changes in the swallowing status

  From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).

• Changes in the nutritonal status of study patient's.

  From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).

• Changes in the needs of compensatory treatments in those patients with oropharyngeal dysphagia (fluid adaptation).

  From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).

• Changes in the needs of compensatory treatments in those patients with oropharyngeal dysphagia (nutritional adaptation).

  From April 2020 to September 2021. And at 3 and 6 months follow-up (1st wave).

Study Arms (1)

Patients infected by SARS-CoV-2

Patients infected by SARS-CoV-2 at the Hospital de Mataró, Hospital de St. Jaume i Sta. Magdalena and other medicalized facilities in Mataró.

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

Interventions

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

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.

Also known as: Nutritional evaluation (NRS 2002), Fluid and nutritional adaptation registry (needs of compensatory treatment), Clinical complications at 6 months

Patients infected by SARS-CoV-2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All COVID-19 + patients admitted to the CSdM more than 48h from April to the end of the pandemic (estimation: N=300). There are 3 main phenotypes of patients with OD related to COVID-19: 1. ICU. Patients in/post ICU with OD associated with intubation/mechanical ventilation or OD associated with tracheotomies or NG tubes (critical or semi-critical patients). 2. Wards. Patients with respiratory infection/pneumonia/respiratory insufficiency, some of them with a severe disease needing high concentration of oxygen or noninvasive mechanical ventilation (acute patients with some complexity). 3. Post-acute COVID-19 patients discharged from acute hospitals to rehabilitation centers, nursing homes or medicalized facilities (sub-acute patients, convalescents).

You may qualify if:

• Infected patients (COVID-19 + by PCR or according to physician's criteria in the medical report of the patient at discharge) admitted to the CSdM more than 48 h.
• Patients able to be explored regarding OD and nutritional status according to their physician's criteria (fully awake patients in a stable respiratory situation and optimal PaO2/FiO2).

You may not qualify if:

• Uncontrolled risk of infection for healthcare professionals (HCP) (according to the safety considerations stated below).

Sponsors & Collaborators

• Hospital de Mataró: lead
• Centro Investigación Biomédica en Red de Enfermedades Hepáticas Digestivas: collaborator

Study Sites (1)

Consorci Sanitari del Maresme (Hospital de Mataró)

Mataró, Barcelona, 08301, Spain

Location

Related Publications (9)

• Clave P, Shaker R. Dysphagia: current reality and scope of the problem. Nat Rev Gastroenterol Hepatol. 2015 May;12(5):259-70. doi: 10.1038/nrgastro.2015.49. Epub 2015 Apr 7.

  PMID: 25850008 BACKGROUND

• Ortega O, Martin A, Clave P. Diagnosis and Management of Oropharyngeal Dysphagia Among Older Persons, State of the Art. J Am Med Dir Assoc. 2017 Jul 1;18(7):576-582. doi: 10.1016/j.jamda.2017.02.015. Epub 2017 Apr 12.

  PMID: 28412164 BACKGROUND

• Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.

  PMID: 19140539 BACKGROUND

• Rofes L, Arreola V, Mukherjee R, Clave P. Sensitivity and specificity of the Eating Assessment Tool and the Volume-Viscosity Swallow Test for clinical evaluation of oropharyngeal dysphagia. Neurogastroenterol Motil. 2014 Sep;26(9):1256-65. doi: 10.1111/nmo.12382. Epub 2014 Jun 9.

  PMID: 24909661 BACKGROUND

• Clave P, Arreola V, Romea M, Medina L, Palomera E, Serra-Prat M. Accuracy of the volume-viscosity swallow test for clinical screening of oropharyngeal dysphagia and aspiration. Clin Nutr. 2008 Dec;27(6):806-15. doi: 10.1016/j.clnu.2008.06.011. Epub 2008 Sep 11.

  PMID: 18789561 BACKGROUND

• Kaiser MJ, Bauer JM, Ramsch C, Uter W, Guigoz Y, Cederholm T, Thomas DR, Anthony P, Charlton KE, Maggio M, Tsai AC, Grathwohl D, Vellas B, Sieber CC; MNA-International Group. Validation of the Mini Nutritional Assessment short-form (MNA-SF): a practical tool for identification of nutritional status. J Nutr Health Aging. 2009 Nov;13(9):782-8. doi: 10.1007/s12603-009-0214-7.

  PMID: 19812868 BACKGROUND

• Todorovic V. Detecting and managing undernutrition of older people in the community. Br J Community Nurs. 2001 Feb;6(2):54-60. doi: 10.12968/bjcn.2001.6.2.54.

  PMID: 11927872 BACKGROUND

• Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.

  PMID: 12765673 BACKGROUND

• Martin-Martinez A, Ortega O, Vinas P, Arreola V, Nascimento W, Costa A, Riera SA, Alarcon C, Clave P. COVID-19 is associated with oropharyngeal dysphagia and malnutrition in hospitalized patients during the spring 2020 wave of the pandemic. Clin Nutr. 2022 Dec;41(12):2996-3006. doi: 10.1016/j.clnu.2021.06.010. Epub 2021 Jun 15.

  PMID: 34187698 DERIVED

MeSH Terms

Conditions

Deglutition Disorders; COVID-19

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Pere Clavé, MD, PhD

  Hospital de Mataró

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research and Academic Development at CSdM

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 15, 2020
• Study Start: April 14, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Locations

ES (1)