Which Place for High Flow Oxygen in ICU ?
Primary Purpose
Hypoxemia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Optiflow
Sponsored by
About this trial
This is an interventional supportive care trial for Hypoxemia focused on measuring hypoxemia, high flow oxygen therapy, respiratory failure
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
High Flow Oxygen
Conventionnal
Arm Description
Patients receiving oxygen via high flow oxygen therapy (Optiflow)
patients receiving oxygen via conventional way (low flow)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Change from baseline in Ventilation criteria
respiratory rate (RR), arterial partial CO2 pressure (PCO2), pH, sterno-mastoid EMG
Full Information
NCT ID
NCT02080208
First Posted
January 9, 2014
Last Updated
January 29, 2016
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02080208
Brief Title
Which Place for High Flow Oxygen in ICU ?
Official Title
Which Place for High Flow Oxygen in Intensive Care Unit ?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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..
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxemia
Keywords
hypoxemia, high flow oxygen therapy, respiratory failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Flow Oxygen
Arm Type
Experimental
Arm Description
Patients receiving oxygen via high flow oxygen therapy (Optiflow)
Arm Title
Conventionnal
Arm Type
No Intervention
Arm Description
patients receiving oxygen via conventional way (low flow)
Intervention Type
Device
Intervention Name(s)
Optiflow
Intervention Description
patients receive oxygen via high flow oxygen therapy during 20 minutes
Primary Outcome Measure Information:
Title
Change from baseline in Oxygenation criteria
Description
Arterial oxygen partial pressure (PO2), oxygen saturation by pulse oximetry (SpO2), arterial PO2/FiO2, positive end expiratory pressure (PEEP)
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Change from baseline in Ventilation criteria
Description
respiratory rate (RR), arterial partial CO2 pressure (PCO2), pH, sterno-mastoid EMG
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
change from baseline in hemodynamic criteria
Description
cardiac frequency, arterial blood pressure
Time Frame
20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilie Bialais, PhD Student
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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