OmeLEtte: Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19).

Sponsor
Ignacio Saez de la Fuente (Other)
Overall Status
Completed
CT.gov ID
NCT05012267
Collaborator
(none)
61
1
2
7.1
8.6

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Other: 16-hour PP
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
61 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
OptiMal pronE Position LEnghT in Patients With acuTE Respiratory Distress Syndrome Due to COVID-19.
Actual Study Start Date :
Mar 25, 2021
Actual Primary Completion Date :
Oct 27, 2021
Actual Study Completion Date :
Oct 27, 2021

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control group

48 hours of PP

Experimental: Experimental group

Anytime from 16 hours when PaO2/FiO2 ≥ 150 mmHg with a FiO2 < 60%

Other: 16-hour PP
PP according to previous study

Outcome Measures

Primary Outcome Measures

  1. Ventilator-free days at 28 days [28 days]

    Number of days from successfully weaning to day 28

  2. Ventilator-free days at 60 days [60 days]

    Number of days from successfully weaning to day 60

Secondary Outcome Measures

  1. Survival [60 days]

    Mortality during ICU or hospital admission

  2. ICU and Hospital stay [Hospital admission]

    Days of stay

  3. Evolution of respiratory parameters [ICU admission]

    Measurement of mechanical ventilation parameters.

  4. PP complications [ICU admission]

    Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event.

Other Outcome Measures

  1. Enteral nutrition administration [ICU admission]

    Nutritional intake.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient above 18 year-old.

  • Diagnosis of severe ARDS due to COVID-19 under invasive mechanical ventilation,

  • Meet criteria for PP: PaO2/FiO2 < 150 millimeters of mercury column (mmHg), PEEP ≥ 5 Centimeters of Water (cmH2O), FiO2 ≥ 60.

Exclusion Criteria:
  • No consent for the study.

  • PP contraindicated (( elevated intracranial pressure, massive hemoptysis, recent tracheal surgery or sternotomy, unstable hemodynamic status, recent pacemaker implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis fracture or pregnancy).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital 12 de Octubre Madrid Spain 28041

Sponsors and Collaborators

  • Ignacio Saez de la Fuente

Investigators

  • Principal Investigator: Ignacio Sáez, MD, Hospital Universitario 12 de Octubre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ignacio Saez de la Fuente, Ignacio Saez de la Fuente, MD, Hospital Universitario 12 de Octubre
ClinicalTrials.gov Identifier:
NCT05012267
Other Study ID Numbers:
  • OMELETTE
First Posted:
Aug 19, 2021
Last Update Posted:
Oct 28, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ignacio Saez de la Fuente, Ignacio Saez de la Fuente, MD, Hospital Universitario 12 de Octubre

Study Results

No Results Posted as of Oct 28, 2021