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

October 27, 2021 updated by: Ignacio Saez de la Fuente

OptiMal pronE Position LEnghT in Patients With acuTE Respiratory Distress Syndrome Due to COVID-19.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28041
        • Hospital 12 de Octubre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventilator-free days at 28 days
Time Frame: 28 days
Number of days from successfully weaning to day 28
28 days
Ventilator-free days at 60 days
Time Frame: 60 days
Number of days from successfully weaning to day 60
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 60 days
Mortality during ICU or hospital admission
60 days
ICU and Hospital stay
Time Frame: Hospital admission
Days of stay
Hospital admission
Evolution of respiratory parameters
Time Frame: ICU admission
Measurement of mechanical ventilation parameters.
ICU admission
PP complications
Time Frame: ICU admission
Proportion of Patients experiencing accidental removal of catheters, endotracheal tube obstruction or any serious adverse event.
ICU admission

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enteral nutrition administration
Time Frame: ICU admission
Nutritional intake.
ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ignacio Saez de la Fuente

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2021

Primary Completion (Actual)

October 27, 2021

Study Completion (Actual)

October 27, 2021

Study Registration Dates

First Submitted

August 11, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Actual)

October 28, 2021

Last Update Submitted That Met QC Criteria

October 27, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OMELETTE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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