Which Place for High Flow Oxygen in ICU ?

Which Place for High Flow Oxygen in Intensive Care Unit ?

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.

Study Overview

• Status: Completed
• Conditions: Hypoxemia
• Intervention / Treatment: Device: Optiflow

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..

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Flow Oxygen; Patients receiving oxygen via high flow oxygen therapy (Optiflow)	Device: Optiflow; patients receive oxygen via high flow oxygen therapy during 20 minutes
No Intervention: Conventionnal; patients receiving oxygen via conventional way (low flow)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Ventilation criteria	respiratory rate (RR), arterial partial CO2 pressure (PCO2), pH, sterno-mastoid EMG	20 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in hemodynamic criteria	cardiac frequency, arterial blood pressure	20 minutes

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Emilie Bialais, PhD Student, Cliniques Universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 9, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Estimate): February 1, 2016
• Last Update Submitted That Met QC Criteria: January 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: respiratory failure; hypoxemia; high flow oxygen therapy
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hypoxia
• Other Study ID Numbers: OptSCM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No