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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Asan Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01166256
First received: July 19, 2010
Last updated: July 20, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Hypoxemic Respiratory Failure
 Device: Non-invasive ventilation
Device: High flow nasal cannula system
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • Success rate of treatment in two groups [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • compliance of treatment [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance

  • adverse event [ Time Frame: up to 28 days ] [ Designated as safety issue: Yes ]
  • hospital length of stay [ Time Frame: up to 90 days ] [ Designated as safety issue: No ]
  • Hospital mortality [ Time Frame: up to 90 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 74
Study Start Date: July 2010
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01166256

Locations
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     popeyes0212@hanmail.net    
Sponsors and Collaborators
Asan Medical Center
Investigators
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
  More Information

No publications provided

Responsible Party: Chae-Man Lim, Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
ClinicalTrials.gov Identifier: NCT01166256     History of Changes
Other Study ID Numbers: HFNCinAHRF
Study First Received: July 19, 2010
Last Updated: July 20, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
respiratory failure

Additional relevant MeSH terms:
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013