Which Place for High Flow Oxygen in ICU ?
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2011
Typical duration for not_applicable
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
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
March 6, 2014
CompletedFebruary 1, 2016
January 1, 2016
2.3 years
January 9, 2014
January 29, 2016
Conditions
Keywords
Outcome Measures
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)
20 minutes
Secondary Outcomes (1)
Change from baseline in Ventilation criteria
20 minutes
Other Outcomes (1)
change from baseline in hemodynamic criteria
20 minutes
Study Arms (2)
High Flow Oxygen
EXPERIMENTALPatients receiving oxygen via high flow oxygen therapy (Optiflow)
Conventionnal
NO INTERVENTIONpatients receiving oxygen via conventional way (low flow)
Interventions
patients receive oxygen via high flow oxygen therapy during 20 minutes
Eligibility Criteria
You may qualify if:
- Spontaneously breathing patient requiring administration at least 40% oxygen, or,
- Patient under mechanical ventilation, during respiratory weaning.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emilie Bialais, PhD Student
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- physiotherapist PhD student
Study Record Dates
First Submitted
January 9, 2014
First Posted
March 6, 2014
Study Start
February 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 1, 2016
Record last verified: 2016-01
Data Sharing
- IPD Sharing
- Will not share