Hyperoxemia and Ventilator-associated Pneumonia (SOH-VAP)

July 4, 2022 updated by: University Hospital, Lille

Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

534

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59037
        • CHU de LILLE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of time spent with hyperoxemia during ICU stay
Time Frame: 28 days after ICU admission
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)
Time Frame: 28 days after ICU admission
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
28 days after ICU admission
percentage of time spent with hyperoxemia during ICU stay, and the presence of acute lung injury
Time Frame: 28 days after ICU admission
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
28 days after ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2018

Primary Completion (Actual)

April 30, 2022

Study Completion (Actual)

April 30, 2022

Study Registration Dates

First Submitted

February 6, 2018

First Submitted That Met QC Criteria

February 13, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 4, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016_73
  • 2017-A01934-49 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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