Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT01166256|
Recruitment Status : Unknown
Verified July 2010 by Asan Medical Center.
Recruitment status was: Recruiting
First Posted : July 21, 2010
Last Update Posted : July 21, 2010
|Condition or disease||Intervention/treatment||Phase|
|Acute Hypoxemic Respiratory Failure||Device: Non-invasive ventilation Device: High flow nasal cannula system||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||July 2011|
Experimental: High-flow nasal cannula
In this arm,patients with acute hypoxemic respiratory failure were treated with high-flow nasal cannula system(Optiflow, Fisher & Paykel, Auckland, New Zealand) to achieve SpO2 >92% or PaO2 >65 mmHg.
Device: High flow nasal cannula system
High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 >92% or PaO2 >65 mmHg.
Other Name: Optiflow(Fisher & Paykel, Auckland, New Zealand)
Active Comparator: Non-invasive ventilation
In this arm, patients with acute hypoxemic respiratory failure is treated with the bi-level positive airways pressure mode (BiPAP Vision, Respironics Inc., Murrysville, PA) S/T mode to achieve SpO2 >92% or PaO2 >65 mmHg.
Device: Non-invasive ventilation
Noninvasive ventilation: The inspiratory(IPAP) and expiratory positive airways pressure (EPAP), and the levels of FiO2 is set achieve SpO2 >92% or PaO2 >65 mmHg.
Other Name: (BiPAP Vision, Respironics Inc., Murrysville, PA)
- Success rate of treatment in two groups [ Time Frame: up to 28 days ]Successful treatment is to avoid intubation and achieve PaO2 >75 mmHg without respiratory distress for 24 hours while spontaneously breathing oxygen provided by a Venturi device at FiO2 0.50.
- compliance of treatment [ Time Frame: up to 28 days ]Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance
- adverse event [ Time Frame: up to 28 days ]
- hospital length of stay [ Time Frame: up to 90 days ]
- Hospital mortality [ Time Frame: up to 90 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01166256
|Korea, Republic of|
|Asan Medical Center, University of Ulsan College of Medicine||Recruiting|
|Seoul, Korea, Republic of|
|Contact: Woo-hyun Cho, M.D. +82-2-3010-3139 firstname.lastname@example.org|
|Study Chair:||Chae-Man Lim, M.D.||Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea|