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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
Sponsor:
Information provided by:
Asan Medical Center

July 19, 2010
July 21, 2010
July 21, 2010
July 2010
July 2011   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
Acute hypoxemic respiratory failure may require invasive mechanical ventilation. However, invasive mechanical ventilation is associated with a variety of complications. Non-invasive ventilation has been presented as an alternative treatment but controversy remains. The investigators hypothesize that high-flow nasal cannula system is effective enough to prevent intubation in acute hypoxemic respiratory failure and not inferior to non-invasive ventilation.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Hypoxemic Respiratory Failure
  • 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)
  • 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)
  • 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.
    Intervention: Device: High flow nasal cannula system
  • 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.
    Intervention: Device: Non-invasive ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
74
Same as current
Not Provided
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age above 18
  • patients with acute hypoxemic respiratory failure

Exclusion Criteria:

  • age < 18 years
  • hypercapnia (arterial carbon dioxide tension (PaCO2) >45mmHg) at admission
  • need for emergency intubation, including cardiopulmonary resuscitation
  • recent esophageal, facial or cranial trauma or surgery
  • severely decreased consciousness (Glasgow coma score <11)
  • cardiogenic shock or severe hemodynamic instability
  • systolic blood pressure <90 mmHg associated with decreased urinary output(<20 mL.h-1) despite fluid repletion and use of vasoactive agents
  • lack of co-operation
  • altered mental status with decreased consciousness and/or evidence of inability to understand or lack of willingness to co-operate with the procedures
  • tracheotomy or other upper airway disorders
  • severe ventricular arrhythmia or active myocardial ischemia
  • active upper gastrointestinal bleeding
  • inability to clear respiratory secretions
  • more than one severe organ dysfunction in addition to respiratory failure
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01166256
HFNCinAHRF
Not Provided
Not Provided
Not Provided
Chae-Man Lim, Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Asan Medical Center
Not Provided
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
Asan Medical Center
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP