Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure (OPTI O2)

This study has been terminated.
(Difficulty of recruitment)
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01243918
First received: November 18, 2010
Last updated: October 4, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Acute Respiratory Failure
Other: Oxygen therapy delivery systems

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Calcul of the ratio PaO2/FiO2 [ Time Frame: one hour after each system used ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • number of participants with adverse events [ Designated as safety issue: No ]

    The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:

    • number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
    • impact on work of breathing: measure of respiratory frequency and blood gas
    • measure of positive and expiratory pressure

  • measure of respiratory frequency and blood gas [ Designated as safety issue: No ]

    The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:

    • number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
    • impact on work of breathing: measure of respiratory frequency and blood gas
    • measure of positive and expiratory pressure

  • measure of positive and expiratory pressure [ Designated as safety issue: No ]

    The secondary outcomes are to understand the mechanisms of action of Optiflow system and to evaluate the tolerance of this system:

    • number of adverse events: respiratory events, trophic troubles, subjective events (comfort, dryness of mucous membranes, gastric distension, preferred system), serious hemodynamic and cardiovascular events
    • impact on work of breathing: measure of respiratory frequency and blood gas
    • measure of positive and expiratory pressure


Enrollment: 16
Study Start Date: November 2010
Study Completion Date: June 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VNI/Optiflow, Immunodeficient patients
VNI = non invasive ventilation
Other: Oxygen therapy delivery systems
T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2
Experimental: Optiflow/VNI, Immunodeficient patients
VNI = non invasive ventilation
Other: Oxygen therapy delivery systems
T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2
Experimental: Ospal/Optiflow, Immunocompetent patients Other: Oxygen therapy delivery systems
T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2
Experimental: Optiflow/Ospal, Immunocompetent patients Other: Oxygen therapy delivery systems
T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01243918

Locations
France
Nantes University Hospital
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Noëlle BRULE, Dr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01243918     History of Changes
Other Study ID Numbers: 10/6-D
Study First Received: November 18, 2010
Last Updated: October 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Acute respiratory failure
Oxygen therapy delivery systems
Non invasive ventilation
High concentration mask
Hypoxemic pneumonia

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders

ClinicalTrials.gov processed this record on April 16, 2014