Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults patients with acute respiratory failure requiring intubation
Exclusion Criteria
- •Encephalopathy or coma, cardiac resuscitation
Arms & Interventions
1
Non Invasive Ventilation
Intervention: Non Invasive Ventilation (Procedure)
Outcomes
Primary Outcomes
The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.
Time Frame: the first week
Secondary Outcomes
- The mean drop in SpO2 during endotracheal intubation.(during the intubation)
- Mortality(in reanimation)
- Number of organ failures (SOFA score >2)(during the 7 days after intubation)
- ICU length of stay(during the stay in reanimation)