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Completed

NCT Number: NCT00472160

Preoxygenation Using NIV in Hypoxemic Patients

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.

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Key information

Conditions

Critical Illness Disease Attributes Hypoxemia Hypoxia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital de Bobigny

Bobigny, 93009, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults patients with acute respiratory failure requiring intubation

Exclusion criteria

  • Encephalopathy or coma, cardiac resuscitation

Treatment and study plan

non invasive ventilation

Procedure

Non Invasive Ventilation

Primary outcomes

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

    Time frame: the first week

Secondary outcomes

  1. The mean drop in SpO2 during endotracheal intubation.

    Time frame: during the intubation

  2. Number of organ failures (SOFA score >2)

    Time frame: during the 7 days after intubation

  3. ICU length of stay

    Time frame: during the stay in reanimation

  4. Mortality

    Time frame: in reanimation

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients

Acronym: PREOXY

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
May 11, 2007
Registry last updated
Mar 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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