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

NCT01166256 | Unknown Phase 2

• 1 other identifier: HFNCinAHRF
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypoxemic Respiratory Failure

Keywords

respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• compliance of treatment

  up to 28 days

• adverse event

  up to 28 days

• hospital length of stay

  up to 90 days

• Hospital mortality

  up to 90 days

Study Arms (2)

High-flow nasal cannula

EXPERIMENTAL

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

Non-invasive ventilation

ACTIVE COMPARATOR

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

Interventions

Non-invasive ventilation DEVICE

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.

Also known as: (BiPAP Vision, Respironics Inc., Murrysville, PA)

Non-invasive ventilation

High flow nasal cannula system DEVICE

High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 \>92% or PaO2 \>65 mmHg.

Also known as: Optiflow(Fisher & Paykel, Auckland, New Zealand)

High-flow nasal cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18
• patients with acute hypoxemic respiratory failure

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Chae-Man Lim, M.D.

  Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 21, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Last Updated: July 21, 2010

Record last verified: 2010-07

Locations

KR (1)