PREoxygenation for the Intubation of Hypoxemic Patients: Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation (PREONIV)

U

University Hospital, Clermont-Ferrand

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Adult Patients
Requiring Intubation
Patient Covered by French Health Care System
Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200)

Treatments

Procedure: - standard oxygenation

Study type

Interventional

Funder types

Other

Identifiers

NCT01782430
2012-A00778-35 (Registry Identifier)
CHU-0141

Details and patient eligibility

About

Prospective, randomized clinical multicentric study, in ICU, during preoxygenation for the intubation of hypoxemic patients.

Full description

Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients

Enrollment

132 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • adults patients
  • requiring intubation and hypoxemia (defined by PaO2/FiO2 below 200)
  • patient covered by french health care system

Exclusion criteria

  • patient refusal
  • intubation for other causes (excluding hypoxemia)
  • impossibility to measure pulse oxymetry value
  • contraindication for NIV : vomiting
  • NIV intolerance
  • cardiac arrest during intubation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

132 participants in 3 patient groups

Standard oxygenation
Experimental group
Description:
Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients
Treatment:
Procedure: - standard oxygenation
High flow nasal oxygen therapy
Experimental group
Description:
Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients
Treatment:
Procedure: - standard oxygenation
invasive ventilation (VNI)
Other group
Description:
Prospective randomized clinical multicentric study in ICU, comparing standard oxygenation, high flow nasal oxygen therapy and non invasive ventilation (NIV) , with pulse oxymetry values (SpO2), during preoxygenation for hypoxemic patients
Treatment:
Procedure: - standard oxygenation

Trial contacts and locations

1

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Central trial contact

Patrick LACARIN

Data sourced from clinicaltrials.gov

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