Hyperoxemia and Ventilator-associated Pneumonia (SOH-VAP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03434821|
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : June 30, 2020
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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||534 participants|
|Official Title:||Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia|
|Actual Study Start Date :||March 15, 2018|
|Estimated Primary Completion Date :||April 2021|
|Estimated Study Completion Date :||April 2021|
- VAP occurrence [ Time Frame: 28 days after ICU admission ]hyperoxemia at ICU admission (PaO2 >120 mmHg)
- 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.
- 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
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434821
|Contact: Saad Nseir, MD,PhD||03 20 44 44 95 ext +33||Saadalla.NSEIR@chru-lille.fr|
|CHU de Lille||Recruiting|
|Lille, France, 59037|
|Contact: Saad Nseir, MD, PhD|
|Principal Investigator:||Saad Nseir, MD,PhD||University Hospital, Lille|