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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.
Full description
Design: 1) 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.
Aims:
1.1)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.
1.2)To validate an early intervention including fluid thickening and nutritional support.
1.3)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.
2.1) To compare the three first waves of the pandemic in the hospitalization period (clinical, swallowing, nutritional status and mortality).
Study population
All COVID-19 patients admitted to the CSdM more than 48h from April to the end of the pandemic:
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
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.
* There will be no follow-up in the comparative study between the 3 firsts waves of the pandemic.
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.
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.
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.
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605 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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