Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Not Applicable

Terminated

• Conditions: Acute Respiratory Failure
• Interventions: Other: Oxygen therapy delivery systems

• Registration Number: NCT01243918
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-18
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Primary Completion: 2012-10
• Study Completion: 2013-06
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-04
• Last Update Posted: 2013-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VNI/Optiflow, Immunodeficient patients	Oxygen therapy delivery systems	VNI = non invasive ventilation
Optiflow/VNI, Immunodeficient patients	Oxygen therapy delivery systems	VNI = non invasive ventilation
Ospal/Optiflow, Immunocompetent patients	Oxygen therapy delivery systems	-
Optiflow/Ospal, Immunocompetent patients	Oxygen therapy delivery systems	-

Primary Outcome Measures

Name	Time	Method
Calcul of the ratio PaO2/FiO2	one hour after each system used	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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France