Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Acute Respiratory Failure Clinical Trial

— OPTI O2  

Official title:

Evaluation of Oxygen Therapy Delivery Systems in Hypoxemic Acute Respiratory Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01243918
• Other study ID #: 10/6-D
• Status: Terminated
• Phase: N/A
• First received: November 18, 2010
• Last updated: October 4, 2013
• Start date: November 2010
• Est. completion date: June 2013

Study information

• Verified date: October 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	one hour after each system used	No
Secondary	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		No
Secondary	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		No
Secondary	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		No