Predominantly sleeping in the non-supine position could improve oxygenation and thereby shorten the disease course in admitted COVID-19 patients.
ID
Bron
Verkorte titel
Aandoening
COVID-19
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Hospital length of stay (days).
Achtergrond van het onderzoek
Rationale: Prone positioning improves oxygenation in mechanically ventilated ARDS patients and is currently widely applied in COVID-19 patients in ICUs. Up to 20% of COVID-19 patients on the general ward may require ICU admission for hypoxic respiratory failure and are predominantly admitted during the night. We hypothesize that predominantly sleeping in the non-supine position could improve oxygenation and thereby shorten the disease course.
Objective: To investigate whether non-supine positioning during the night in COVID-19 patients admitted to the hospital ward shortens hospital length of stay.
Study design: Randomized, placebo-controlled single-center study.
Study population: Patients aged ≥ 18 years, admitted to the hospital ward with a proven SARS-CoV-2 infection, suffering from COVID-19.
Intervention (if applicable): Prevent a supine position during sleep by the use of a Sleep Position Trainer, a small wearable device that trains patients to not sleep on their back by using gentle vibrations (1:1 randomization). In both groups sleep position will be continuously registered.
Main study parameters/endpoints: Hospital length of stay (days).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Considering the major impact of the COVID-19 pandemic on healthcare systems in the Netherlands but also worldwide, strategies to improve oxygenation and thereby possibly reduce hospital admission days are of major clinical and social importance. Sleep Position Trainers are known to be a safe and patient friendly method of decreasing the proportion of supine sleep time in OSAS patients.
Doel van het onderzoek
Predominantly sleeping in the non-supine position could improve oxygenation and thereby shorten the disease course in admitted COVID-19 patients.
Onderzoeksopzet
Admission and hospital discharge.
Onderzoeksproduct en/of interventie
Prevent a supine position during sleep by the use of a Sleep Position Trainer, a small wearable device that trains patients to not sleep on their back by using gentle vibrations (1:1 randomization). In both groups sleep position will be continuously registered.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age ≥ 18 years
- Admitted to one of our COVID-19 cohort units
- PCR confirmed COVID-19
- Any form of oxygen therapy (nasal cannula or high-flow nasal oxygen)
- Able to independently change from supine to non-supine position
- Able to read and speak in the Dutch language
- Signed informed-consent
- No current indication for mechanical ventilation
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- ‘Do not intubate’ order
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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Register | ID |
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NTR-new | NL8538 |
Ander register | METC Franciscus Gasthuis & Vlietland : Not assigned yet. |