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

November 18, 2010
October 4, 2013
November 2010
October 2012   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01243918 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure
Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Respiratory Failure
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: VNI/Optiflow, Immunodeficient patients
    VNI = non invasive ventilation
    Intervention: Other: Oxygen therapy delivery systems
  • Experimental: Optiflow/VNI, Immunodeficient patients
    VNI = non invasive ventilation
    Intervention: Other: Oxygen therapy delivery systems
  • Experimental: Ospal/Optiflow, Immunocompetent patients
    Intervention: Other: Oxygen therapy delivery systems
  • Experimental: Optiflow/Ospal, Immunocompetent patients
    Intervention: Other: Oxygen therapy delivery systems
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
16
June 2013
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01243918
10/6-D
No
Nantes University Hospital
Nantes University Hospital
Not Provided
Principal Investigator: Noëlle BRULE, Dr Nantes University Hospital
Nantes University Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP