Hyperoxemia and Ventilator-associated Pneumonia

Mechanical Ventilation Clinical Trial

— SOH-VAP  

Official title:

Impact of Hyperoxemia on Incidence of Ventilator-associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03434821
• Other study ID #: 2016_73
• Secondary ID: 2017-A01934-49
• Status: Completed
• Start date: March 15, 2018
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 534
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mechanical Ventilation
• Pneumonia
• Pneumonia, Ventilator-Associated

Locations

Country	Name	City	State
France	CHU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAP occurrence	hyperoxemia at ICU admission (PaO2 >120 mmHg)	28 days after ICU admission
Secondary	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.	28 days after ICU admission
Secondary	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	28 days after ICU admission
Secondary	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	28 days after ICU admission