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Hyperoxemia and Ventilator-associated Pneumonia (SOH-VAP)

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ClinicalTrials.gov Identifier: NCT03434821
Recruitment Status : Recruiting
First Posted : February 15, 2018
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease
Mechanical Ventilation

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Study Type : Observational
Estimated Enrollment : 534 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. VAP occurrence [ Time Frame: 28 days after ICU admission ]
    hyperoxemia at ICU admission (PaO2 >120 mmHg)


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients hospitalized in intensive care unit requiring invasive mechanical ventilation (IV) for more than 48 hours.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03434821


Contacts
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Contact: Saad Nseir, MD,PhD 03 20 44 44 95 ext +33 Saadalla.NSEIR@chru-lille.fr

Locations
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France
CHU de Lille Recruiting
Lille, France, 59037
Contact: Saad Nseir, MD, PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Saad Nseir, MD,PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03434821    
Other Study ID Numbers: 2016_73
2017-A01934-49 ( Other Identifier: ID-RCB number,ANSM )
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Hyperoxemia
ventilator-associated
pneumonia
critical illness
Additional relevant MeSH terms:
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Pneumonia, Ventilator-Associated
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Infection