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

Phase 2

• Conditions: Acute Hypoxemic Respiratory Failure
• Interventions: Device: High flow nasal cannula system; Device: Non-invasive ventilation

• Registration Number: NCT01166256
• Lead Sponsor: Asan Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-07
• Study Start: 2010-07
• Study First Submitted: 2010-07-19
• Study First Submitted QC: 2010-07-20
• Last Update Submitted: 2010-07-20
• Study First Posted: 2010-07-21
• Last Update Posted: 2010-07-21
• Primary Completion: 2011-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flow nasal cannula	High flow nasal cannula system	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.
Non-invasive ventilation	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.

Primary Outcome Measures

Name	Time	Method
Success rate of treatment in two groups	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of