No registrations found.
ID
Source
Brief title
Health condition
COVID-19
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospital length of stay (days).
Secondary outcome
- In-hospital all-cause mortality
- ICU admission and intubation rate
- ICU admission days
- Oxygen requirement during hospital admission (mean and median FiO2)
- Percentage of supine sleep time
- Change in oxygen saturation (SpO2) during supine sleep time
Background summary
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.
Study objective
Predominantly sleeping in the non-supine position could improve oxygenation and thereby shorten the disease course in admitted COVID-19 patients.
Study design
Admission and hospital discharge.
Intervention
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.
Inclusion criteria
- 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
Exclusion criteria
- ‘Do not intubate’ order
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8538 |
| Other | METC Franciscus Gasthuis & Vlietland : Not assigned yet. |