Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
|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 ]
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|