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OpenTrials
Completed

NCT Number: NCT02080208

Which Place for High Flow Oxygen in ICU ?

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.

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Key information

Conditions

Hypoxemia Hypoxia Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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..

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Optiflow

Device

patients receive oxygen via high flow oxygen therapy during 20 minutes

Primary outcomes

  1. Change from baseline in Oxygenation criteria

    Time frame: 20 minutes

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

Secondary outcomes

  1. Change from baseline in Ventilation criteria

    Time frame: 20 minutes

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

Other outcomes

  1. change from baseline in hemodynamic criteria

    Time frame: 20 minutes

    cardiac frequency, arterial blood pressure

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Which Place for High Flow Oxygen in Intensive Care Unit ?

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 6, 2014
Registry last updated
Feb 1, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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