NCT03434821

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
534

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

March 15, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 6, 2022

Status Verified

June 1, 2022

Enrollment Period

4.1 years

First QC Date

February 6, 2018

Last Update Submit

July 4, 2022

Conditions

Mechanical Ventilation

Keywords

Hyperoxemiaventilator-associatedpneumoniacritical illness

Outcome Measures

Primary Outcomes (1)

  • VAP occurrence

    hyperoxemia at ICU admission (PaO2 \>120 mmHg)

    28 days after ICU admission

Secondary Outcomes (3)

  • percentage of time spent with hyperoxemia during ICU stay

    28 days after ICU admission

  • relationship between hyperoxemia at ICU admission and the presence of acute lung injury (ALI)

    28 days after ICU admission

  • percentage of time spent with hyperoxemia during ICU stay, and the presence of acute lung injury

    28 days after ICU admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

PneumoniaCritical Illness

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Saad Nseir, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 15, 2018

Study Start

March 15, 2018

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 6, 2022

Record last verified: 2022-06

Locations

FR(1)