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CompletedNCT02080208Updated Feb 1, 2016

Which Place for High Flow Oxygen in ICU ?

An interventional study of Optiflow in Hypoxemia, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2016-02-01.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

Patients with respiratory failure often need oxygen and/or ventilatory support. Patients who need only oxygen support, usually received low flow oxygen (\< 15 Liters / min), as well as in respiratory weaning. Now new devices can be used. They provide high flow oxygen with different benefits. This high flow devices provide exact fraction of inspired oxygen (FiO2), allows a positive end expiratory pressure and supplies a wash out flow. The hypothesis of this study is that the high flow oxygen enable more efficient oxygen administration than conventional oxygen. In addition, it would improve the effectiveness of the ventilation of the patient, through flushing the dead space.

Read the detailed description

The investigators hypothesized that when using high flow oxygen therapy, respiratory failure is relieved, as well as ventilation failure, so accessories are less stressed muscles, and this can be demonstrated by the electromyography (EMG) of sterno-mastoid..

02

Conditions studied

  • Hypoxemia

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Keywords

  • hypoxemia
  • high flow oxygen therapy
  • respiratory failure
03

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 20 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

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Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: patients with respiratory failure.

  • Spontaneously breathing patient requiring administration at least 40% oxygen, or,
  • Patient under mechanical ventilation, during respiratory weaning.

Exclusion Criteria:

  • Facial trauma, active hemoptysis, pneumothorax, thoraco-abdominal surgery or upcoming intubation for spontaneously breathing patients.
  • Neuromuscular disease, altered consciousness or agitation for patients under mechanical ventilation.
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Study design

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

Study arms

  • Experimental
    High Flow Oxygen

    Patients receiving oxygen via high flow oxygen therapy (Optiflow)

    Device: Optiflow

  • No intervention
    Conventionnal

    patients receiving oxygen via conventional way (low flow)

Interventions

  • DeviceOptiflow

    patients receive oxygen via high flow oxygen therapy during 20 minutes

06

What researchers measure

Primary outcomes

  1. Change from baseline in Oxygenation criteria

    Arterial oxygen partial pressure (PO2), oxygen saturation by pulse oximetry (SpO2), arterial PO2/FiO2, positive end expiratory pressure (PEEP)

    Time frame: 20 minutes

Secondary outcomes

  1. Change from baseline in Ventilation criteria

    respiratory rate (RR), arterial partial CO2 pressure (PCO2), pH, sterno-mastoid EMG

    Time frame: 20 minutes

Other outcomes

  1. change from baseline in hemodynamic criteria

    cardiac frequency, arterial blood pressure

    Time frame: 20 minutes

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02080208
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Bialais (physiotherapist PhD student, Cliniques universitaires Saint-Luc- Université Catholique de Louvain) — Principal investigator
First posted
Mar 6, 2014
Start date
Feb 2011
Primary completion
Jun 2013
Completion
Jun 2013
Last update
Feb 1, 2016

Study contacts

Emilie Bialais, PhD Student
principal investigator · Cliniques universitaires Saint-Luc

Oversight

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

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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