Hyperoxemia and Ventilator-associated Pneumonia

Completed

• Conditions: Mechanical Ventilation

• Registration Number: NCT03434821
• Lead Sponsor: University Hospital, Lille

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 available

Study Timeline

• Study First Submitted: 2018-02-06
• Study First Submitted QC: 2018-02-13
• Study First Posted: 2018-02-15
• Study Start: 2018-03-15
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-07-04
• Last Update Posted: 2022-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAP occurrence	28 days after ICU admission	hyperoxemia at ICU admission (PaO2 \>120 mmHg)

Secondary Outcome Measures

Name	Time	Method
percentage of time spent with hyperoxemia during ICU stay, and the presence of acute lung injury	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
percentage of time spent with hyperoxemia during ICU stay	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.
relationship between hyperoxemia at ICU admission and the presence of acute lung injury (ALI)	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

Trial Locations

Locations (1)

CHU de Lille; 🇫🇷 Lille, France