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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014