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

Asan Medical Center

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Acute Hypoxemic Respiratory Failure

Treatments: Device: Non-invasive ventilation; Device: High flow nasal cannula system

Study type: Interventional

Funder types: Other

Identifiers

NCT01166256

HFNCinAHRF

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

High-flow nasal cannula

Experimental group

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.

Treatment:

Device: High flow nasal cannula system

Non-invasive ventilation

Active Comparator group

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.

Treatment:

Device: Non-invasive ventilation