Acute Hypoxemic Respiratory FailurePhase 2/3NCT01166256
Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
A Phase 2/3 study testing Non-invasive ventilation and High flow nasal cannula system in people with Acute Hypoxemic Respiratory Failure, run by Asan Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure
- What is being tested?
- Non-invasive ventilation and High flow nasal cannula system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Jul 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18
- patients with acute hypoxemic respiratory failure
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center, University of Ulsan College of Medicine
Seoul
Woo-hyun Cho, M.D., +82-2-3010-3139, popeyes0212@hanmail.net
About this study
Official title: Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
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
- Being tested
- Non-invasive ventilation, High flow nasal cannula system
- Keywords
- respiratory failure
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive ventilationDevice
Also called (BiPAP Vision, Respironics Inc., Murrysville, PA)
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.
High flow nasal cannula systemDevice
Also called Optiflow(Fisher & Paykel, Auckland, New Zealand)
High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 >92% or PaO2 >65 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Non-invasive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 28 days
Secondary outcomes (4)
compliance of treatment
Withdrawl of non-invasive ventilation or high-flow nasal cannula system without intubation because of intolerance
Measured: up to 28 days
adverse event
Measured: up to 28 days
hospital length of stay
Measured: up to 90 days
Hospital mortality
Measured: up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Chae-Man Lim, M.D., Study chair, Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166256
- Sponsor's protocol ID
- HFNCinAHRF
- Status last verified
- Jul 2010
- First submitted
- 19 Jul 2010
- Last updated
- 21 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-labeled, Randomized Controlled Trial of Comparison Between High-flow Nasal Cannula System and Non-invasive Ventilation in Acute Hypoxemic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01166256
- Acronym / sponsor ID
- HFNCinAHRF
- Conditions
- Acute Hypoxemic Respiratory Failure
- Keywords
- respiratory failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2011 (estimated)
- First posted
- 21 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-flow nasal cannula | Experimental | Device: High flow nasal cannula systemIn 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 | Active comparator | Device: Non-invasive ventilationIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age above 18
- patients with acute hypoxemic respiratory failure
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive ventilationAlso: (BiPAP Vision, Respironics Inc., Murrysville, PA)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. | Device | Non-invasive ventilation |
| High flow nasal cannula systemAlso: Optiflow(Fisher & Paykel, Auckland, New Zealand)High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 >92% or PaO2 >65 mmHg. | Device | High-flow nasal cannula |
Primary outcome
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.
4 secondary outcomes
compliance of treatment
Time frame: up to 28 days
adverse event
Time frame: up to 28 days
hospital length of stay
Time frame: up to 90 days
Hospital mortality
Time frame: up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asan Medical Center, University of Ulsan College of Medicine
Seoul, South Korea
Chae-Man Lim, M.D. study chair
Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Non-invasive ventilation and High flow nasal cannula system in people with Acute Hypoxemic Respiratory Failure, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of treatment in two groups (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2010.