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Oropharyngeal Dysphagia in Patients With COVID-19

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ClinicalTrials.gov Identifier: NCT04346212
Recruitment Status : Recruiting
First Posted : April 15, 2020
Last Update Posted : September 23, 2020
Sponsor:
Collaborator:
Centro Investigación Biomédica en Red de Enfermedades Hepáticas Digestivas
Information provided by (Responsible Party):
Pere Clave, Hospital de Mataró

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.

Condition or disease Intervention/treatment
Oropharyngeal Dysphagia COVID-19 Sars-CoV2 Nutrition Diagnostic Test: Swallowing evaluation with the EAT-10 and the volume-viscosity swallowing test (V-VST)

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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)
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.
Other Names:
  • Nutritional evaluation (NRS 2002)
  • Fluid and nutritional adaptation registry (needs of compensatory treatment)
  • Clinical complications at 6 months




Primary Outcome Measures :
  1. Changes in the prevalence of oropharyngeal dysphagia [ Time Frame: From April to December 2020. And at 3 and 6 months follow-up. ]
    Changes in the prevalence of oropharyngeal dysphagia according to a clinical assessment tool, the Volume-Viscosity Swallowing Test (V-VST).


Secondary Outcome Measures :
  1. Changes in the swallowing screening [ Time Frame: From April to December 2020. And at 3 and 6 months follow-up. ]
    Changes in the eating assessment tool (EAT-10 score). A tool that goes from 0 to 40 points and indicates that the patient is at risk of oropharyngeal dysphagia if he/she presents 3 or more points

  2. Changes in the swallowing status [ Time Frame: From April to December 2020. And at 3 and 6 months follow-up. ]
    Changes in the percentage of patients with impairements in efficacy and/or safety of swallow.

  3. Changes in the nutritonal status of study patient's. [ Time Frame: From April to December 2020. And at 3 and 6 months follow-up. ]
    Changes in the nutritional status of study patients (% malnourished, at risk of malnutrition or wellnourished).

  4. Changes in the needs of compensatory treatments in those patients with oropharyngeal dysphagia (fluid adaptation). [ Time Frame: From April to December 2020. And at 3 and 6 months follow-up. ]
    Changes in the fluid (volume and viscosity) requirements of study patients.

  5. Changes in the needs of compensatory treatments in those patients with oropharyngeal dysphagia (nutritional adaptation). [ Time Frame: From April to December 2020. And at 3 and 6 months follow-up. ]
    Changes in the nutritional adaptation requirements (type of diet and need of nutritional supplementation).

  6. Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (incidence of readmissions). [ Time Frame: 3 and 6 months from inclusion. ]
    Changes in the incidence of hospital readmissions: number of hospital readmissions/patient/6 months.

  7. Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (prevalence of readmissions). [ Time Frame: 3 and 6 months from inclusion. ]
    Changes in the prevalence: % of patients with hospital readmissions during the follow-up.

  8. Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (number of visits to emergency department). [ Time Frame: 3 and 6 months from inclusion. ]
    Incidence: number of visits to the emergency department/patient/ 3 or 6 months.

  9. Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (percentage of visits to emergency department). [ Time Frame: 3 and 6 months from inclusion. ]
    Prevalence: % of patients visiting the emergency department during the follow-up.

  10. Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (respiratory complications). [ Time Frame: 3 and 6 months from inclusion. ]
    Incidence of respiratory infections (including pneumonia, and COPD exacerbations).

  11. Changes in the clinical complications at 3 and 6 months follow up from patient's medical history (mortality). [ Time Frame: 3 and 6 months from inclusion. ]
    3 and 6 months mortality.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04346212


Contacts
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Contact: Pere Clavé, MD, PhD +34937417700 ext 1046 pere.clave@ciberehd.org

Locations
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Spain
Consorci Sanitari del Maresme (Hospital de Mataró) Recruiting
Mataró, Barcelona, Spain, 08301
Contact: Pere Clavé, MD, PhD    +34937417700 ext 1046    pere.clave@ciberehd.org   
Sub-Investigator: Viridiana Arreola, SLP         
Sub-Investigator: Alberto Martín, Nurse         
Sub-Investigator: Alícia Costa, Dietitian         
Sub-Investigator: Weslania Nascimento, SLP, PhD         
Sub-Investigator: Silvia Carrión, MD, PhD         
Sub-Investigator: Mireia Bolívar, Pharmacist         
Sub-Investigator: Stephanie Riera, SLP         
Sub-Investigator: Paula Viñas, Dietitian         
Sub-Investigator: Omar Ortega, MSc, PhD         
Sponsors and Collaborators
Hospital de Mataró
Centro Investigación Biomédica en Red de Enfermedades Hepáticas Digestivas
Investigators
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Principal Investigator: Pere Clavé, MD, PhD Hospital de Mataró
Publications:

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Responsible Party: Pere Clave, Director of Research and Academic Development at CSdM, Hospital de Mataró
ClinicalTrials.gov Identifier: NCT04346212    
Other Study ID Numbers: COVID_OD
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases