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Preoxygenation Using NIV in Hypoxemic Patients

Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00472160
Acronym
PREOXY
Enrollment
200
Registered
2007-05-11
Start date
2007-06-30
Completion date
2010-06-30
Last updated
2011-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Hypoxemia

Keywords

Preoxygenation, Non Invasive Ventilation, Continuous Positive Airway Pressure,, Intubation,, Organ failure

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.

Interventions

PROCEDURENon Invasive Ventilation

Non Invasive Ventilation

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adults patients with acute respiratory failure requiring intubation

Exclusion criteria

* Encephalopathy or coma, cardiac resuscitation

Design outcomes

Primary

MeasureTime frame
The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.the first week

Secondary

MeasureTime frame
The mean drop in SpO2 during endotracheal intubation.during the intubation
Number of organ failures (SOFA score >2)during the 7 days after intubation
ICU length of stayduring the stay in reanimation
Mortalityin reanimation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026