Back to resultsComparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
Primary Purpose
Acute Hypoxemic Respiratory Failure
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Non-invasive ventilation
High flow nasal cannula system
Sponsored by
About this trial
This is an interventional treatment trial for Acute Hypoxemic Respiratory Failure focused on measuring respiratory failure
Eligibility 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
Sites / Locations
- Asan Medical Center, University of Ulsan College of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High-flow nasal cannula
Non-invasive ventilation
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Success rate of treatment in two groups
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
Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance
adverse event
hospital length of stay
Hospital mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01166256
Brief Title
Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Asan Medical Center
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Hypoxemic Respiratory Failure
Keywords
respiratory failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-flow nasal cannula
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-invasive ventilation
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Non-invasive ventilation
Other Intervention Name(s)
(BiPAP Vision, Respironics Inc., Murrysville, PA)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
High flow nasal cannula system
Other Intervention Name(s)
Optiflow(Fisher & Paykel, Auckland, New Zealand)
Intervention Description
High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 >92% or PaO2 >65 mmHg.
Primary Outcome Measure Information:
Title
Success rate of treatment in two groups
Description
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.
Time Frame
up to 28 days
Secondary Outcome Measure Information:
Title
compliance of treatment
Description
Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance
Time Frame
up to 28 days
Title
adverse event
Time Frame
up to 28 days
Title
hospital length of stay
Time Frame
up to 90 days
Title
Hospital mortality
Time Frame
up to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chae-Man Lim, M.D.
Organizational Affiliation
Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Woo-hyun Cho, M.D.
Phone
+82-2-3010-3139
Email
popeyes0212@hanmail.net
12. IPD Sharing Statement
Learn more about this trial
Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
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