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.

Study Overview

• Status: Unknown
• Conditions: Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: High flow nasal cannula system; Device: Non-invasive ventilation

• Study Type: Interventional
• Enrollment (Anticipated): 74
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Asan Medical Center, University of Ulsan College of Medicine
    • Contact: Woo-hyun Cho, M.D.; Phone Number: +82-2-3010-3139; Email: popeyes0212@hanmail.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: (BiPAP Vision, Respironics Inc., Murrysville, PA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compliance of treatment	Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance	up to 28 days
adverse event		up to 28 days
hospital length of stay		up to 90 days
Hospital mortality		up to 90 days

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: July 19, 2010
• First Submitted That Met QC Criteria: July 20, 2010
• First Posted (Estimate): July 21, 2010

Study Record Updates

• Last Update Posted (Estimate): July 21, 2010
• Last Update Submitted That Met QC Criteria: July 20, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: respiratory failure
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: HFNCinAHRF