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Oropharyngeal Dysphagia in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date April 10, 2020
First Posted Date April 15, 2020
Last Update Posted Date September 23, 2020
Actual Study Start Date April 14, 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 21, 2020)
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).
Original Primary Outcome Measures
 (submitted: April 14, 2020)
Prevalence of oropharyngeal dysphagia [ Time Frame: From April to July 2020. ]
Prevalence of oropharyngeal dysphagia according to a clinical assessment tool, the Volume-Viscosity Swallowing Test (V-VST).
Change History
Current Secondary Outcome Measures
 (submitted: September 21, 2020)
  • 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
  • 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.
  • 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).
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures
 (submitted: April 14, 2020)
  • Swallowing screening [ Time Frame: From April to July 2020. ]
    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
  • Swallowing status. [ Time Frame: From April to July 2020. ]
    Percentage of patients with impairements in efficacy and/or safety of swallow.
  • Nutritonal status of study patient's. [ Time Frame: From April to July 2020. ]
    Nutritional status of study patients (% malnourished, at risk of malnutrition or wellnourished).
  • Needs of compensatory treatments in those patients with oropharyngeal dysphagia (fluid adaptation). [ Time Frame: From April to July 2020. ]
    Fluid (volume and viscosity) requirements of study patients.
  • Needs of compensatory treatments in those patients with oropharyngeal dysphagia (nutritional adaptation). [ Time Frame: From April to July 2020. ]
    Nutritional adaptation requirements (type of diet and need of nutritional supplementation).
  • Clinical complications at 6 months follow up from patient's medical history (incidence of readmissions). [ Time Frame: 6 months from inclusion. ]
    Incidence of hospital readmissions: number of hospital readmissions/patient/6 months.
  • Clinical complications at 6 months follow up from patient's medical history (prevalence of readmissions). [ Time Frame: 6 months from inclusion. ]
    Prevalence: % of patients with hospital readmissions during the follow-up.
  • Clinical complications at 6 months follow up from patient's medical history (number of visits to emergency department). [ Time Frame: 6 months from inclusion. ]
    Incidence: number of visits to the emergency department/patient/6 months.
  • Clinical complications at 6 months follow up from patient's medical history (percentage of visits to emergency department). [ Time Frame: 6 months from inclusion. ]
    Prevalence: % of patients visiting the emergency department during the follow-up.
  • Clinical complications at 6 months follow up from patient's medical history (respiratory complications). [ Time Frame: 6 months from inclusion. ]
    Incidence of respiratory infections (including pneumonia, and COPD exacerbations).
  • Clinical complications at 6 months follow up from patient's medical history (mortality). [ Time Frame: 6 months from inclusion. ]
    6 months mortality.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Oropharyngeal Dysphagia in Patients With COVID-19
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
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.
Detailed Description

Design: prospective study in SARS-CoV-2 infected patients admitted to the CSdM more than 48h with 2 follow-up points at 3/6 months after discharge.

Aim:

  1. To assess the prevalence of OD, nutritional risk, the needs of compensatory treatment and complications at 3/6 month follow up of patients admitted by COVID-19 in Hospital de Mataró, Hospital St. Jaume and the medicalized Atenea Hotel, Mataró (Barcelona), Spain.
  2. To validate an early intervention including fluid thickening and nutritional support.
  3. In addition, we would like to know if those patients with OD and those with OD and MN have worse prognosis than those without these conditions.

    • Inclusion criteria: Infected patients (COVID-19 + PCR or according to physician's criteria at discharge medical report) admitted to the CSdM >48h; 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).

Study population

All COVID-19 patients admitted to the CSdM more than 48h from April to the end of the pandemic:

  1. ICU. Patients in/post ICU with OD associated with intubation/mechanical ventilation or OD associated with tracheotomies or NG tubes (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).

Sample size calculation: Taking into account the main study variable and that we will do an opportunistic recruitment (admitted patients), a sample size of 315 subjects randomly selected will suffice to estimate with a 95% confidence and a precision +/-5.5 percent units, a population percentage considered to be around 55.0% (estimated OD prevalence). It has been anticipated a replacement rate of 0%.

Study variables

  • Main variable: prevalence of OD and risk of malnutrition among COVID-19 patients.
  • Secondary variables: needs of nutritional supplementation, texture-modified diets, use of thickeners and patient's adherence to compensatory measures, functional capacity, comorbidities, nutritional analytical parameters, weight, clinical severity (including pneumonia severity), neurological symptoms, pharmacological treatment, ICU admission, and hospital readmissions, visits to emergency department, respiratory infections and mortality at 3 and 6 months follow-up. Clinical prognosis in those patients with OD and/or MN compared to those without these conditions.

Study visits/evaluations/management 4 evaluation points: 1) admission; 2) discharge; and 3-4) follow up at 3 months and 6 months. According to the first evaluation, an interventional plan (management) will be prescribed in order to improve patient's swallowing, feeding and nutritional status during admission. All the evaluations and interventional plans are currently being performed as standard clinical practice and will be obtained from patient's medical history record. Study variables will be grouped in 3 different assessments: a) clinical assessment; b) swallowing assessment; and c) nutritional assessment.

  1. Admission*: there will be 2 admission evaluation points, the first one 24-48h after admission (pre-admission data) and the second one during admission (admission data).

    1.1.Clinical evaluation: patient origin (community, nursing home, socio-health center), functional status before, during admission and at discharge (Barthel index), comorbidities (Charlson index), clinical symptoms before and during admission, neurological symptoms, ICU admission and length of stay, respiratory infection, its symptoms, severity and length from the week before admission, prescribed pharmacological treatment, hospitalization days and mortality during admission.

    1.2.Swallowing evaluation: anamnesis, EAT-10 questionnaire (screening), clinical swallowing assessment with volume-viscosity swallowing test (V-VST) at admission and tolerance and adherence with the recommendations (volume and viscosity) during admission.

    1.3.Nutritional evaluation: anthropometrical measurements and nutrition-related questions pre and post-admission, analytical parameters at admission and during admission (albumin, pre-albumin, cholesterol, total proteins, lymphocytes, ferritin and C-reactive protein), NRS2002 at admission and at discharge and nutritional recommendations during admission (ONS, type of diet and intake) and patient's adherence.

  2. Discharge:

    2.1.Codification at discharge: SARS-CoV2 pneumonia, OD, respiratory infection, aspiration pneumonia, malnutrition or others.

    2.2.Recommendations at discharge: fluid and nutritional recommendations at discharge (volume and viscosity, oral nutritional supplementation and type of diet).

    *After evaluations, healthcare professionals will give to the patients clinical recommendations on the use of thickeners, texture-modified diets and nutritional supplementation if required.

  3. Follow up (3/6 months): we will collect clinical data, information about swallowing and nutritional status and needs through the electronical medical history of the patients and by telephone call. Patients will receive new recommendations on fluid and nutritional adaptation and nutritional supplementation if required. The follow-up evaluations will include:

3.1.Clinical evaluation: mortality (date), patient residence (community, nursing home, socio-health center), functional status (Barthel index), and hospital resources consumption/clinical outcomes (hospital readmissions, visits to the emergency department, and respiratory infections).

3.2.Swallowing evaluation: anamnesis, EAT-10 (swallowing screening); if positive, virtual clinical swallowing assessment with the V-VST, and fluid adaptation recommendations.

3.3.Nutritional evaluation: anthropometrical measurements (current weight), ONS intake (time taken from discharge), textural diet adaptation if needed and compliance with the previous recommendations, NRS2002, and analytical parameters (albumin, cholesterol, ferritin, C-reactive protein) if the patient had a blood analysis during the previous month.

Management of patients with COVID-19, OD and MN:

After admission in our health care centers, COVID-19 patients will be screened by a speech and language pathologist (SLP) for OD with specific questions and the V-VST, and nutritional status with the NRS2002. In addition, clinical data of patients will be recorded during admission. Those patients with a NRS2002 ≥ 3 points, will require ONS, that will be given in two formats (liquid or viscosity-adapted) depending on the swallowing status. Those patients with less than 70 years will receive 2 instead of 1/day. According to patient's masticatory and swallowing hability they will receive texture-modified diets in 3 different formats: 1) normal, 2) easy mastication diet, and 3) puree. Normal diet is composed by 1750Kcal/70g protein; if the patient is at nutritional risk or malnourished (NRS2002≥3) he/she will also receive a high caloric-proteic diet with 2000Kcal/90g protein. Finally there will be a fluid adaptation according to the results of the V-VST with 3 different viscosities: 1)liquid, 2)250mPa•s, and 3)800mPa•s. During admission patients will be managed by the SLPs and the nutritionist team of the healthcare centers. Just before discharge, patients will be re-evaluated and swallowing and nutritional recommendations will be given adapted to the new status of the patient by using the same criteria. On a nutritional level, just before discharge, patients will be re-evaluated by the team of dietitians to detect those patients who have not yet improved their nutritional status and therefore will need to continue taking ONS after discharge. The criteria for maintaining or not maintaining the prescription at discharge will be those corresponding to a normal dietary assessment, such as: anorexia, not having recovered weight or insufficient intake due to vomiting, nausea or other causes not related to hospital food. Other criteria may be included at the discretion of the clinical professional. This group will be dispensed ONS for at least 1 month after discharge.

We will collect also data on patient's destination, functional capacity, weight loss, admission to the ICU and clinical data at discharge. Finally, patients will be followed-up at 3/6 months for clinical complications through their electronic medical history.

Main study procedures and variables

  • EAT-10: is a simple 10-item questionnaire to screen for the risk of dysphagia (score>2, risk of OD) (Belafsky P 2008, Ann Otol Rhinol Laryngol; Rofes L 2014, Neurogastroenterol Motil).
  • V-VST: is a validated clinical test to explore safety and efficacy of swallow and select the optimal bolus volume and viscosity for each patient with/at risk of OD. It uses different volumes (5, 10 and 20mL) and viscosities (250mPa•s, liquid and 800mPa•s) (thickener Nutilis Clear) to evaluate clinical signs of impaired efficacy and safety of swallow. We will apply a simplified V-VST with only 1 volume (10mL) and the 3 usual viscosities in order to reduce the hospital burden and stress for the patient (Clavé P 2008, Clin Nutr). Recommendations on fluid adaptation given to the patient according to the results of the test will be recorded.
  • Nutritional status: a nutritional evaluation is done to COVID-19 patients according to their phenotype. We will use the nutritional risk screening (NRS 2002), a validated nutritional screening tool for hospitalized adult patients and has been recommended by a recent guideline for COVID-19 admitted patients (Ying-Hui Jin, 2020, Mil Med Res). If the patient scores 3 or more points is considered to be in nutritional risk and a more comprehensive nutritional evaluation should be performed and nutritional supplementation applied. Recommendations on nutritional adaptation given to the patient (adaptation of texture/calories/proteins and nutritional supplementation) according to the results of the tests will be recorded.
  • Other study variables collected from patient's medical history: patient origin and destination at discharge, hospitalization days, admission to the ICU, myopathy post-ICU and length of stay in the ICU, symptomatology before and during admission (fever, cough, dyspnea, diarrhea, vomiting, ageusia, anosmia, headache, polymyalgia), neurological symptoms during admission (seizures, encephalitis, delirium, headache, dyskinesia, stroke, parenthesis, ataxia, encephalitis), functionality with the Barthel index (pre-admission, admission and discharge), comorbidities with the Charlson score, respiratory infections during admission and its severity and type, use of oxygen therapy, pronation, prescribed treatment, anthropometric measurements (weight at discharge, weight loss), use and tolerability of oral nutritional supplements, nutritional intake, use of enteral or parenteral nutrition, biochemical parameters at admission and discharge (pre-albumin, albumin, cholesterol, total proteins, lymphocytes, ferritin and C-reactive protein), diagnostics at discharge (SARS-CoV2 pneumonia, OD, respiratory infection, aspiration pneumonia, malnutrition or others), and intra-hospital mortality.
  • Follow-up (3 and 6 months): we will collect data of clinical complications from the medical history of the patient and by telephone call: swallowing, nutritional status and needs (including analytical parameters), hospital readmissions, visits to the emergency department, incidence of respiratory infections (including pneumonia, COPD exacerbations) and mortality.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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).
Condition
  • Oropharyngeal Dysphagia
  • COVID-19
  • Sars-CoV2
  • Nutrition
Intervention 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
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Swallowing evaluation with the EAT-10 and the volume-viscosity swallowing test (V-VST)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 21, 2020)
300
Original Estimated Enrollment
 (submitted: April 14, 2020)
100
Estimated Study Completion Date January 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pere Clavé, MD, PhD +34937417700 ext 1046 pere.clave@ciberehd.org
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04346212
Other Study ID Numbers COVID_OD
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Pere Clave, Hospital de Mataró
Study Sponsor Hospital de Mataró
Collaborators Centro Investigación Biomédica en Red de Enfermedades Hepáticas Digestivas
Investigators
Principal Investigator: Pere Clavé, MD, PhD Hospital de Mataró
PRS Account Hospital de Mataró
Verification Date September 2020