NCT04834947

Brief Summary

Prone position in non-intubated patient has shown some respiratory physiological benefits. Prone positioning in patient intubated with ARDS has shown hemodynamic benefits. We aim to compare hemodynamic assessment before and after prone positioning in non-intubated patient with COVID 19 pneumonia. The study hypothesis is that prone positioning in non-intubated patient improve right ventricular preload, reduce afterload and increase Cardiac index compared to supine position.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

April 15, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
Last Updated

April 8, 2021

Status Verified

March 1, 2021

Enrollment Period

8 months

First QC Date

April 6, 2021

Last Update Submit

April 6, 2021

Conditions

Keywords

COVID 19prone positionhemodynamic effectspontaneous ventilation

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic effect

    Cardiac index

    Cardiac index will be recorded before, just after prone position and after return to supine position.

Study Arms (1)

Prone position in non-intubated COVID19 , before and after.

Patients with non-intubated COVID19 pneumoniae for whom the clinician has decided to try prone positioning to increase the PaO2 in a context of hypoxemia with O2 requirement.

Procedure: prone position

Interventions

Choice of prone positioning a patient is at the discretion of the anesthesia physician.

Prone position in non-intubated COVID19 , before and after.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients scheduled for cadiac surgery wih cardiopulmonary bypass

You may qualify if:

  • Adult patient
  • COVID 19 pneumonias with Hypoxemia
  • for whom prone positioning has been decided by the attending physician.

You may not qualify if:

  • Mechanical ventilation
  • ECLS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie-Réanimation, Hôpital Louis Pradel,

Bron, France

Location

MeSH Terms

Conditions

COVID-19Pneumonia, Viral

Interventions

Prone Position

Condition Hierarchy (Ancestors)

PneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Matthias JACQUET LAGREZE, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

April 15, 2021

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

April 8, 2021

Record last verified: 2021-03

Locations