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

NCT ID: NCT01166256

Last Updated: 2010-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Brief Summary

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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

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Conditions

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Acute Hypoxemic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

High flow nasal cannula system

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Non-invasive ventilation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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(BiPAP Vision, Respironics Inc., Murrysville, PA) Optiflow(Fisher & Paykel, Auckland, New Zealand)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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

Principal Investigators

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Chae-Man Lim, M.D.

Role: STUDY_CHAIR

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

Locations

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Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Woo-hyun Cho, M.D.

Role: primary

+82-2-3010-3139

Other Identifiers

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HFNCinAHRF

Identifier Type: -

Identifier Source: org_study_id

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