Oropharyngeal Dysphagia in Patients With COVID-19

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, specially the older and more frail ones. 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, severe nutritional and respiratory complications such as malnutrition, lower respiratory tract infections and aspiration pneumonia, hospital readmissions and increased mortality (during hospitalization and at mid-term). In addition it has a high impact on healthcare resources consumption and in patient's functionality and quality of life.

The aim of this observational study is to know the prevalence of OD in these patients and to know their needs of compensatory treatment, and complications during 6 month follow up.

Study design:

Prospective observational study in patients infected by SARS-CoV-2 admitted to the CSdM more than 48h.

Aim:

To know the prevalence of OD and the needs of compensatory treatment of patients admitted by COVID-19 in a General Hospital (Hospital de Mataró i Hospital St. Jaume i Sta. Magdalena), and complications during 6 month follow up.

Eligibility criteria:

- Inclusion criteria: Infected patients (COVID-19 + by PCR) 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).

Study population We will include all COVID-19 positive patients admitted to the CSdM more than 48h from April to the end of the pandemic.

There are three main new phenotypes of patients with OD related to COVID-19 infection:

1. ICU. Patients in/post ICU with OD associated with intubation/mechanical ventilation or OD associated with tracheotomies or NG tubes (Code: Purple Color, 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 (Code: Red/Orange, acute patients with some complexity).

3. Post-acute COVID-19 patients discharged from acute hospitals to rehabilitation centers, nursing homes or medicalized facilities including hotels, etc. (Code: Yellow/Green, sub-acute patients, convalescents).

Study variables/procedures SAFETY CONSIDERATIONS WHEN EXPLORING A PATIENT WITH COVID-19

All the procedures developed in the study will be performed following the recommendations given in the expert opinion statement in COVID-19 and OD endorsed by:

1. CIBERehd. Strategic Action in Oropharyngeal Dysphagia. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas. https://www.ciberehd.org/

2. Societat Catalana de Digestologia. Pla Estratègic en Disfàgia Orofaríngia. www.scdigestologia.org.

3. Hospital de Mataró. Consorci Sanitari del Maresme. https://www.csdm.cat/

Reference: BASIC PROCEDURES TO ASSESS AND TREAT OROPHARYNGEAL DYSPHAGIA IN PATIENTS WITH COVID-19 INFECTION. EXPERT OPINON PRACTICAL GUIDANCE FROM HOSPITAL DE MATARÓ, CATALONIA, SPAIN (V1, April 6th, 2020).

Study variables include the following explorations:

- Eating-assessment tool (EAT-10): the EAT-10 is a simple 10-item questionnaire to screen for the risk of dysphagia. It takes less than five minutes and and a score higher than 2 out of 40 indicates that the patient is at risk of dysphagia and a more comprehensive evaluation is needed.

- Volume-viscosity swallowing test (V-VST)*: the 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. The V-VST uses different volumes (5, 10 and 20mL) and viscosities (nectar (250mPa.s), liquid and pudding-like (800mPa.s)) to evaluate clinical signs of impaired efficacy and safety of swallow. Diagnostic sensitivity and specificity for OD are 0.94 and 0.88 respectively, and the reliability of V-VST is also high with an overall Kappa value of 0.628 (95% CI = 0.45-0.78). In this study we will apply a simplified V-VST with only one volume (intermediate (10mL)) and the three usual viscosities in order to reduce the reduce hospital burden and stress for the patient. Recommendations on fluid adaptation given to the patient according to the results of the test will be recorded.

* The V-VST and adaptation of fluids for COVID-19 patients will be performed with the thickener Nutilis Clear, the one used at CSdM.

- Nutritional status: a nutritional evaluation is done to COVID-19 patients according to their phenotype. Thus, mini nutritional assessment short-form (MNA-sf) for older patients, and the malnutrition universal screening tool (MUST) and the nutritional risk screening (NRS 2002) for adults (community or hospitalized, respectively) are recorded. The MNA-sf is a simplified version of the MNA and it is standard tool for nutritional evaluation, especially for geriatric patients, to identify patients at risk of malnutrition or malnourished. It is composed by 6 items and the score goes from 0 to 14: 0-7 malnutrition, 8-11 at risk of malnutrition, and 12-14 well nourished. The MUST is a five-step screening tool to identify adults from the community, who are malnourished, at risk of malnutrition, or obese. The NRS 2002 is also a validated nutritional screening tool for hospitalized adult patients. 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.

- Follow-up: we will collect data of clinical complications during 6 months follow-up from the medical history of the patient including: hospital readmissions, visits to the emergency department, incidence of respiratory infections (including pneumonia, and COPD exacerbations) and mortality.

Ethical considerations:

The study will be carried out in accordance with the recommendations of good clinical practice contained in the Helsinki Declaration, the recommendations of the WHO and in accordance with the Law on Biomedical Research 14/2007.

The principal investigator will ensure that the instructions and rules of the protocol are strictly followed. Researchers must inform the participating auxiliary staff about the purpose of the study and will ensure that they are aware of the technical aspects of the study.

The researchers assure the confidentiality of the study data in accordance with the LOPD 3/2018. The data of the study participants will be treated in a dissociated way and codified, so that they cannot be related to their identity. The patient's medical records and other original data are kept for as long as the hospital allows. As the current study is an observational study, a registry about COVID-19 complications based in standard clinical practice at our institution, and for the following reasons, we would like to request to the Ethical Committee the waiver of informed consent:

- All the data will be codified. Patients will only be identified by the health care provider in order to prescribe the optimal texture-modified diet.

- Due to the pandemic period which we are living, the signature of the informed consent, increases the risk of contagious.

- We are in a critical situation with a high health-care assistance pressure and asking for the informed consent for an observational study is not appropriate.

Adverse events will be recorded and communicated to the ethical committee within 24h if they are severe.

The evaluations that will be recorded are done in the current clinical practice and thus, we will not add additional work to the HCPs working on the COVID-19 units.

It is planned to present the study protocol to evaluation by the CEIm of the CSdM, to ensure that the ethical principles of human research are met and that they are modified as it deems appropriate.