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OpenTrials
Completed

NCT Number: NCT03434821

Hyperoxemia and 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. VAP occurrence

    Time frame: 28 days after ICU admission

    hyperoxemia at ICU admission (PaO2 >120 mmHg)

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia

Acronym: SOH-VAP

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2018
Registry last updated
Jul 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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