A Phase 4 interventional study of Non Invasive Ventilation in Critical Illness and Hypoxemia, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-03-28.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 4, Interventional, and Prevention
Critically ill patients are predisposed to oxyhaemoglobin desaturation during intubation. For the intubation of hypoxemic patients, preoxygenation using non invasive ventilation (NIV) is more effective at reducing arterial oxyhaemoglobin desaturation than standard method.
Objectives: To find out whether NIV, as a preoxygenation method, is more effective at reducing the degree of organ dysfunction/failure than standard preoxygenation during the week following endotracheal intubation.
During the inclusion period (at least 10 min and maximum 30 min), the patients ware a high FiO2 mask, driven by 10-15L/min oxygen and are randomly assigned to control or NIV group. Preoxygenation is then performed for a 3 minute period prior to a standardized rapid sequence intubation. For the control group, preoxygenation use a non-re-breather bag-valve mask driven by 15L/min oxygen. Patients allow to breath spontaneously with occasional assists (usual preoxygenation method). For the NIV group, pressure support mode is delivered by an ICU ventilator through a face mask adjusted to obtain an expired tidal volume of 7 to 10 mL/kg. The fraction of inspired oxygen (FiO2) was 100% and we used a PEEP level of 5 cmH2O.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 200 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Non Invasive Ventilation
Procedure: Non Invasive Ventilation
Non Invasive Ventilation
The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.
Time frame: the first week
The mean drop in SpO2 during endotracheal intubation.
Time frame: during the intubation
Number of organ failures (SOFA score >2)
Time frame: during the 7 days after intubation
ICU length of stay
Time frame: during the stay in reanimation
Mortality
Time frame: in reanimation
This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris