NCT01243918

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 7, 2013

Status Verified

October 1, 2013

Enrollment Period

1.9 years

First QC Date

November 18, 2010

Last Update Submit

October 4, 2013

Conditions

Acute Respiratory Failure

Keywords

Acute respiratory failureOxygen therapy delivery systemsNon invasive ventilationHigh concentration maskHypoxemic pneumonia

Outcome Measures

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

    one hour after each system used

Secondary Outcomes (3)

  • number of participants with adverse events

  • measure of respiratory frequency and blood gas

  • measure of positive and expiratory pressure

Study Arms (4)

VNI/Optiflow, Immunodeficient patients

EXPERIMENTAL

VNI = non invasive ventilation

Other: Oxygen therapy delivery systems

Optiflow/VNI, Immunodeficient patients

EXPERIMENTAL

VNI = non invasive ventilation

Other: Oxygen therapy delivery systems

Ospal/Optiflow, Immunocompetent patients

EXPERIMENTAL
Other: Oxygen therapy delivery systems

Optiflow/Ospal, Immunocompetent patients

EXPERIMENTAL
Other: Oxygen therapy delivery systems

Interventions

Oxygen therapy delivery systemsOTHER

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

Optiflow/Ospal, Immunocompetent patientsOptiflow/VNI, Immunodeficient patientsOspal/Optiflow, Immunocompetent patientsVNI/Optiflow, Immunodeficient patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

Study Officials

  • Noëlle BRULE, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2010

First Posted

November 19, 2010

Study Start

November 1, 2010

Primary Completion

October 1, 2012

Study Completion

June 1, 2013

Last Updated

October 7, 2013

Record last verified: 2013-10

Locations

FR(1)