Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure

Asan Medical Center1 site in 1 country74 target enrollmentJuly 2010

ConditionsAcute Hypoxemic Respiratory Failure

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Acute Hypoxemic Respiratory Failure
Sponsor: Asan Medical Center
Enrollment: 74
Locations: 1
Primary Endpoint: Success rate of treatment in two groups
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

July 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Asan Medical Center

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

Outcomes

Primary Outcomes

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.