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Clinical Trials/NCT01243918
NCT01243918TerminatedNot Applicable

Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Nantes University Hospital1 site in 1 country16 target enrollmentStarted: November 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
16
Locations
1
Primary Endpoint
Calcul of the ratio PaO2/FiO2

Study Overview

Brief Summary

The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation).12 immunocompetent patients will compare the successive use of oxygen therapy delivery systems Optiflow®/Ospal® and 12 immunodeficient patients will compare the successive use of systems Optiflow®/Non invasive ventilation.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient hospitalized in the intensive care unit of Nantes University Hospital
  • •Signed informed consent
  • •Patient with not hypercapnic acute hypoxemic respiratory failure
  • •Immunocompetent and immunodeficient patient

Exclusion Criteria

  • •Age < 18 years
  • •Pregnancy
  • •Contra-indication to non invasive ventilation
  • •Allergy to xylocaine
  • •Coagulation troubles
  • •Tracheotomized patient
  • •Urgent indication to intubation
  • •Hypercapnic acute respiratory failure
  • •Acute pulmonary edema
  • •Face or nose malformation

Arms & Interventions

VNI/Optiflow, Immunodeficient patients

Experimental

VNI = non invasive ventilation

Intervention: Oxygen therapy delivery systems (Other)

Optiflow/VNI, Immunodeficient patients

Experimental

VNI = non invasive ventilation

Intervention: Oxygen therapy delivery systems (Other)

Ospal/Optiflow, Immunocompetent patients

Experimental

Intervention: Oxygen therapy delivery systems (Other)

Optiflow/Ospal, Immunocompetent patients

Experimental

Intervention: Oxygen therapy delivery systems (Other)

Outcomes

Primary Outcomes

Calcul of the ratio PaO2/FiO2

Time Frame: one hour after each system used

The main objective of this study is to evaluate the efficiency of the oxygen therapy delivery system Optiflow® compared to 2 others standard oxygen therapy delivery systems (Ospal®, non invasive ventilation) by calculating the ratio PaO2/FiO2

Secondary Outcomes

  • number of participants with adverse events
  • measure of respiratory frequency and blood gas
  • measure of positive and expiratory pressure

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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