Trials / Completed
CompletedNCT05012267
Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).
OptiMal pronE Position LEnghT in Patients With acuTE Respiratory Distress Syndrome Due to COVID-19.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Ignacio Saez de la Fuente · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The OMELETTE study is a randomised, controlled, unicentric, open-label study to prove the noninferiority of reduced prone position (PP) sessions (more tan 16 hours) versus prolonged PP (48 hours).
Detailed description
This is a non-comercial, investigator-driven clinical study developed in a single critical care unit. The study is coordinated by the main investigator from Hospital Universitario 12 de Octubre in Madrid; The sponsorship is performed by Dr. Ignacio Sáez (Hospital Universitario 12 de Octubre). The study was planned according to the Good Clinical Practices. Omelette study has been approved by the Ethics Committee. All participating Patients must give informed consent before any study procedure occur.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | 16-hour PP | PP according to previous study |
Timeline
- Start date
- 2021-03-25
- Primary completion
- 2021-10-27
- Completion
- 2021-10-27
- First posted
- 2021-08-19
- Last updated
- 2021-10-28
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05012267. Inclusion in this directory is not an endorsement.