Hemodynamic Effect of Prone Position in Non-intubated Patient With COVID 19

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04834947

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Pneumonia, Viral	Procedure: prone position

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Hemodynamic Effect of Prone Positioning in Non-intubated Patient With COVID 19 Pneumonia: a Monocentric Prospective Cohort Study

Anticipated Study Start Date :

Apr 15, 2021

Anticipated Primary Completion Date :

Dec 15, 2021

Anticipated Study Completion Date :

Dec 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
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 Choice of prone positioning a patient is at the discretion of the anesthesia physician.

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Mechanical ventilation
ECLS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'Anesthésie-Réanimation, Hôpital Louis Pradel,	Bron		France

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT04834947

Other Study ID Numbers:

69HCL21_0063

First Posted:

Apr 8, 2021

Last Update Posted:

Apr 8, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

COVID 19

prone position

hemodynamic effect

spontaneous ventilation

Additional relevant MeSH terms:

COVID-19

Pneumonia

Pneumonia, Viral

Study Results

No Results Posted as of Apr 8, 2021