Contribution of a Prone Team in Intensive Care During the... | NCT04438941

Studies
Contribution of a Prone Team in Intensive Care During the Covid-19 Epidemic

NCT04438941

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Jun 23, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Sars-CoV2

Interventions

Not provided

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2020Actual

Primary Completion Date

Jun 20, 2020Estimated

Completion Date

Jun 20, 2020Estimated

First Submitted Date

Jun 17, 2020

First Submission Date that Met QC Criteria

Jun 18, 2020

First Posted Date

Jun 19, 2020Actual

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

Jun 19, 2020

Last Update Posted Date

Jun 23, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

SARS-CoV-2 induced by COVID 19, involved the hospitalization of 101,932 patients in France, including 4,007 in intensive care (source: Santé Publique France). Alsace was one of the most affected regions on the metropolitan territory with a large number of patients hospitalized at the University Hospital of Strasbourg.

In view of the seriousness of the epidemic and the rapid arrival of new patients requiring mechanical ventilation, 3 new intensive care units have been created on the NHC site alone, making it possible to accommodate a maximum of 111 patients (compared to 52 during normal periods).

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

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of the effect of prone position in patients with covid-19 in intensive care		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Criteria for inclusion :

Major patient (≥18 years old)
Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD session of which at least one is performed by the dedicated team.
patient who has not expressed, after information, his or her opposition to the re-use of his or her data for the purposes of this research

Exclusion criteria :

Subject who expressed opposition to participating in the study
Subject under guardianship, curatorship or safeguarding of justice

Accepts Healthy Volunteers

Not provided

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

Patient hospitalized in intensive care at the NHC, diagnosed COVID + and requiring a VD session

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Bob HEGER, MD	Contact	33 3.69.55.04.43		Bob.Heger@chru-strasbourg.fr
Saïd CHAYER, PhD, HDR	Contact	33 3 88 11 66 90		said.chayer@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Anesthésie-Réanimation - Nouvel Hôpital Civil	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided