Hyperoxemia and Ventilator-associated Pneumonia | NCT03434821

Studies
Hyperoxemia and Ventilator-associated Pneumonia

NCT03434821

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Jul 6, 2022Actual

Enrollment

534Actual

Phase

Not provided

Conditions

Mechanical Ventilation

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

ID	Type	Description	Link
2017-A01934-49	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2018Actual

Primary Completion Date

Apr 30, 2022Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Feb 6, 2018

First Submission Date that Met QC Criteria

Feb 13, 2018

First Posted Date

Feb 15, 2018Actual

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

Jul 4, 2022

Last Update Posted Date

Jul 6, 2022Actual

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

The aim of this prospective cohort single-center observational study is to determine the impact of hyperoxemia on ventilator-associated pneumonia (VAP) occurrence.

SpO2 will be continuously recorded in order to determine the percentage of time spent with hyperoxemia.
Patients with VAP will be prospectively identified.
Patient characteristics and risk factors for VAP will be prospectively collected.
Oxidant stress will be prospectively investigated in study patients: glutathion peroxidase (GPX), plasmatic superoxyde dismutase (SOD), total plasmatic antioxidant status (SAT) and urinary 8-isoprostanes will be performed at ICU admission, once a week, and at VAP occurrence.

Patients with VAP will be compared with those with no VAP

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

534Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAP occurrence	hyperoxemia at ICU admission (PaO2 >120 mmHg)	28 days after ICU admission

Secondary Outcomes

Measure	Description	Time Frame
percentage of time spent with hyperoxemia during ICU stay	hyperoxemia is defined as peripheral O2 saturation (SaO2)>98%, SaO2 will be measured every 30 seconds, and the percentage of time spent with hyperoxemia will be calculated per day.	28 days after ICU admission
relationship between hyperoxemia at ICU admission and the presence of acute lung injury (ALI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients admitted to the ICU
Expected duration of mechanical ventilation > 48h
Signed informed consent
Social insurance

Exclusion Criteria:

Pregnancy or breast feeding
No informed consent
Hyperbaric oxygen treatment
Prisoners and patients under guardianship

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 hospitalized in intensive care unit requiring invasive mechanical ventilation (IV) for more than 48 hours.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saad Nseir, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Lille		Lille		59037	France

Condition Browse Module

MeSH Terms

ID	Term
D011014	Pneumonia
D016638	Critical Illness

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided