Skip to content

Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01243918
Acronym
OPTI O2
Enrollment
16
Registered
2010-11-19
Start date
2010-11-30
Completion date
2013-06-30
Last updated
2013-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure

Keywords

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

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.

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

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Calcul of the ratio PaO2/FiO2one hour after each system usedThe 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

MeasureTime frameDescription
number of participants with adverse eventsThe 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 gasThe 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 pressureThe 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026