Factors Associated With Failure of HFNO in COVID-19 ICU P... | NCT05798234

Studies
Factors Associated With Failure of HFNO in COVID-19 ICU Patients

NCT05798234

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Apr 4, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

COVID-19 Pneumonia

Interventions

high flow oxygen device

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

Apr 2023

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

May 1, 2023Estimated

Primary Completion Date

Sep 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Apr 3, 2023

First Submission Date that Met QC Criteria

Apr 3, 2023

First Posted Date

Apr 4, 2023Actual

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 3, 2023

Last Update Posted Date

Apr 4, 2023Actual

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

To determine the factors associated with OHD failure in COVID-19 patients admitted to an Intensive Care Unit

Detailed Description

Patients admitted into 1 participating ICU for acute hypoxemic respiratory failure due to COVID-19 between 02/01/2020 and 06/01/2022 will be assessed for OHD failure

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

500Estimated

Name	Type	Description	Arm Group Labels	Other Names
high flow oxygen device	Device	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
High flow oxygen failure	patients requiring initial high flow oxygen but finally intubated	icu stay duration

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients admitted in ICU for COVID-19 pneumonia

Exclusion Criteria:

under immediate ECMO
secondary transferred from another ICU
readmission in the ICU
initial limitation of care

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

Consecutive patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Réanimation Médicale, Hôpital Central		Nancy			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided