Clinical trial NCT00472160: Preoxygenation Using NIV in Hypoxemic Patients
Official title: Preoxygenation Using Noninvasive Ventilation Prior Intubation in Hypoxemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Critical Illness
Hypoxemia
Keywords: Preoxygenation
Non Invasive Ventilation
Continuous Positive Airway Pressure,
Intubation,
Organ failure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Adults patients with acute respiratory failure requiring intubation

Exclusion Criteria:

* Encephalopathy or coma, cardiac resuscitation

Primary outcomes:
measure: The maximum Sequential organ failure assessment (SOFA) score observed during the first week following endotracheal intubation.
timeFrame: the first week
Secondary outcomes:
measure: The mean drop in SpO2 during endotracheal intubation.
timeFrame: during the intubation
measure: Number of organ failures (SOFA score >2)
timeFrame: during the 7 days after intubation
measure: ICU length of stay
timeFrame: during the stay in reanimation
measure: Mortality
timeFrame: in reanimation
Other outcomes:
Locations:
city: Bobigny
country: France
facility: Hopital de Bobigny
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Christophe BAILLARD, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baillard C, Fosse JP, Sebbane M, Chanques G, Vincent F, Courouble P, Cohen Y, Eledjam JJ, Adnet F, Jaber S. Noninvasive ventilation improves preoxygenation before intubation of hypoxic patients. Am J Respir Crit Care Med. 2006 Jul 15;174(2):171-7. doi: 10.1164/rccm.200509-1507OC. Epub 2006 Apr 20.
citation: Baillard C, Prat G, Jung B, Futier E, Lefrant JY, Vincent F, Hamdi A, Vicaut E, Jaber S. Effect of preoxygenation using non-invasive ventilation before intubation on subsequent organ failures in hypoxaemic patients: a randomised clinical trial. Br J Anaesth. 2018 Feb;120(2):361-367. doi: 10.1016/j.bja.2017.11.067. Epub 2017 Nov 23.