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TerminatedNCT01243918OPTI O2Updated Oct 7, 2013

Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

An interventional study of Oxygen therapy delivery systems in Acute Respiratory Failure, sponsored by Nantes University Hospital. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-10-07.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
Difficulty of recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Failure

Keywords

  • Acute respiratory failure
  • Oxygen therapy delivery systems
  • Non invasive ventilation
  • High concentration mask
  • Hypoxemic pneumonia
03

In context

Respiratory Insufficiency

1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.

This study's enrollment of 16 is below the median of 55 across 1,043 interventional studies indexed under Respiratory Insufficiency.

Browse Respiratory Insufficiency studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    VNI/Optiflow, Immunodeficient patients

    VNI = non invasive ventilation

    Other: Oxygen therapy delivery systems

  • Experimental
    Optiflow/VNI, Immunodeficient patients

    VNI = non invasive ventilation

    Other: Oxygen therapy delivery systems

  • Experimental
    Ospal/Optiflow, Immunocompetent patients

    Other: Oxygen therapy delivery systems

  • Experimental
    Optiflow/Ospal, Immunocompetent patients

    Other: Oxygen therapy delivery systems

Interventions

  • OtherOxygen 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

06

What researchers measure

Primary outcomes

  1. Calcul of the ratio PaO2/FiO2

    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

    Time frame: one hour after each system used

Secondary outcomes

  1. number of participants with adverse events

    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

  2. measure of respiratory frequency and blood gas

    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

  3. measure of positive and expiratory pressure

    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

07

Study locations

1 site
  • Nantes University Hospital
    Nantes, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01243918
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Nov 19, 2010
Start date
Nov 2010
Primary completion
Oct 2012
Completion
Jun 2013
Last update
Oct 7, 2013

Study contacts

Noëlle BRULE, Dr
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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