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CompletedNCT03434821SOH-VAPUpdated Jul 6, 2022

Hyperoxemia and Ventilator-associated Pneumonia

An observational study in Mechanical Ventilation, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-06.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
534
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Mechanical Ventilation

Keywords

  • Hyperoxemia
  • ventilator-associated
  • pneumonia
  • critical illness
03

In context

Pneumonia

2,072 studies on the registry are indexed under Pneumonia; 286 are open to participants now.

This study's enrollment of 534 is above the median of 200 across 699 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 630 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy or breast feeding
  • No informed consent
  • Hyperbaric oxygen treatment
  • Prisoners and patients under guardianship
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
534 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. VAP occurrence

    hyperoxemia at ICU admission (PaO2 \>120 mmHg)

    Time frame: 28 days after ICU admission

Secondary outcomes

  1. 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.

    Time frame: 28 days after ICU admission

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

    the presence of hyperoxemia at ICU admission will be determined using blood gazes (arterial PaO2\>120 mmHg). The percentage of patients with hyperoxemia will be compared between patients with Ali, and those with no ALI

    Time frame: 28 days after ICU admission

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

    the percentage of time spent with hyperoxemia during ICU stay will be calculated as mentioned above (outcome 2). This percentage will be compared between patient with ALI and those with no ALI

    Time frame: 28 days after ICU admission

07

Study locations

1 site
  • CHU de Lille
    Lille, 59037, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03434821
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Mar 15, 2018
Primary completion
Apr 30, 2022
Completion
Apr 30, 2022
Last update
Jul 6, 2022

Study contacts

Saad Nseir, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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