Hemodynamic Effect of Prone Position in Non-intubated Pat... | NCT04834947

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

NCT04834947

Sponsor

Hospices Civils de Lyon

Status

Unknown status

Last Update Posted

Apr 8, 2021Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Covid19
Pneumonia, Viral

Interventions

prone position

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2021Estimated

Primary Completion Date

Dec 15, 2021Estimated

Completion Date

Dec 15, 2021Estimated

First Submitted Date

Apr 6, 2021

First Submission Date that Met QC Criteria

Apr 6, 2021

First Posted Date

Apr 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2021

Last Update Posted Date

Apr 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
prone position	Procedure	Choice of prone positioning a patient is at the discretion of the anesthesia physician.	Prone position in non-intubated COVID19 , before and after.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemodynamic effect	Cardiac index	Cardiac index will be recorded before, just after prone position and after return to supine position.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients scheduled for cadiac surgery wih cardiopulmonary bypass

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Matthias JACQUET LAGREZE, MD	Contact	0033472318933		matthias.jacquet-lagrèze@chu-lyon.fr
Jean Luc FELLAHI, MD	Contact	0033472318933		jean-luc.fellahi@chu-lyon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Anesthésie-Réanimation, Hôpital Louis Pradel,		Bron			France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D011024	Pneumonia, Viral

Ancestor Terms

ID	Term
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016684	Prone Position

Ancestor Terms

ID	Term
D011187	Posture
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided