Respiratory FailureNCT02290548
Effect of High-flow Nasal Oxygen on Extubation Outcome
A study testing high flow nasal cannula in people with Respiratory Failure and Congestive Heart Failure, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine whether high flow nasal cannula is effective in lowering the reintubation rate after extubation for high risk patients in medical intensive care unit Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Respiratory Failure, Congestive Heart Failure, COPD
- What is being tested?
- high flow nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2014to Oct 2016
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients mechanically ventilated for > 48 hours and at least one of the following:
- > 65 y/o
- Cardiac failure as the primary indication of mechanical ventilation
- COPD
- Bronchiectasis
- Old pulmonary tuberculosis with destructive lung
Show all 11Show fewer
- Chronic renal failure
- Neuromuscular disease
- BMI > 30
- Inability to manage respiratory secretions
- ARDS
Who cannot join
- Presence of tracheostomy
- Recent facial trauma
- Active gastro-intestinal bleeding
- Planned NIPPV support after extubation
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Mackay Memorial Hospital
Taipei
Kuo Li Kuo, MD
About this study
Official title: Effect of High-flow Nasal Oxygen vs Standard Oxygen Therapy on Extubation Outcome With High Risk of Extubation Failure in Medical ICU Patients
The purpose of this study is to determine whether high flow nasal cannula is effective in lowering the reintubation rate after extubation for high risk patients in medical intensive care unit
Read the detailed description
The study hypothesis is that Optiflow may reduce the extubation failure rate for high risk patients in medical intensive care unit.In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow nasal cannula (Optiflow Airvo2, Fisher \& Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive standard oxygen therapy including nasal cannula or oxygen mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). NIPPV or intubation will be applied in both group if respiratory distress noted. High flow nasal cannula will be tried before NIPPV or intubation in the control group patients.
- Conditions
- Respiratory Failure, Congestive Heart Failure, COPD
- Being tested
- high flow nasal cannula
- Keywords
- high flow nasal cannula, extubation failure
- Medical subject headings
- Respiratory Insufficiency, Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannulaDevice
Also called Optiflow Airvo2 (Fisher & Paykel Healthcare)
High flow nasal cannula used in postextubation patients
| Study group | Role | What they receive |
|---|---|---|
| high flow nasal cannula | Experimental | High flow nasal cannula immediately use after extubation Receives: Device: high flow nasal cannula |
| stanrd oxygen therapy | Placebo comparator | Oxygen cannula or mask after extubation Receives: Device: high flow nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
reintubation rate
Measured: 72 hours after extubation
Secondary outcomes (12)
Need for Non-Invasive Ventilation
Measured: at day 28 after inclusion in the study
ICU readmission rate due to respiratory failure
Measured: at day 28 after inclusion in the study
ICU mortality rate
Measured: at day 28 after inclusion in the study
ICU length of stay
Measured: at day 28 after inclusion in the study
Hospital mortality
Measured: at day 28 after inclusion in the study
Hospital length of stay
Measured: at day 28 after inclusion in the study
Nosocomial pneumonia rate
Measured: at day 28 after inclusion in the study
Desaturation ( SaO2< 90%)
Measured: 72 hours after extubation
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)
Measured: Time Frame: 72 hours after extubation
hypercapnia (PaCO2 > 50)
Measured: 72 hours after extubation
respiratory acidosis (arterial pH < 7.30)
Measured: 72 hours after extubation
severe tachypnea (>40/min)
Measured: 72 hours after extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionSep 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kuo Li Kuo, MD, Principal investigator, +886975835135 lmn4093@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02290548
- Sponsor's protocol ID
- 14MMHIS164
- Status last verified
- Dec 2014
- First submitted
- 2 Oct 2014
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-flow Nasal Oxygen vs Standard Oxygen Therapy on Extubation Outcome With High Risk of Extubation Failure in Medical ICU Patients
- ClinicalTrials.gov ID
- NCT02290548
- Acronym / sponsor ID
- 14MMHIS164
- Conditions
- Respiratory Failure, Congestive Heart Failure, COPD
- Keywords
- high flow nasal cannula, extubation failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 14 Nov 2014 (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.
The purpose of this study is to determine whether high flow nasal cannula is effective in lowering the reintubation rate after extubation for high risk patients in medical intensive care unit
Detailed description
The study hypothesis is that Optiflow may reduce the extubation failure rate for high risk patients in medical intensive care unit.In the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow nasal cannula (Optiflow Airvo2, Fisher \& Paykel Healthcare Ltd., New Zealand) after extubation. The oxygen concentration (FiO2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 L/min.In the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive standard oxygen therapy including nasal cannula or oxygen mask after extubation. The FiO2 will be set to obtain a arterial oxygen saturation (SpO2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). NIPPV or intubation will be applied in both group if respiratory distress noted. High flow nasal cannula will be tried before NIPPV or intubation in the control group patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high flow nasal cannula | Experimental | Device: high flow nasal cannulaHigh flow nasal cannula immediately use after extubation |
| stanrd oxygen therapy | Placebo comparator | Device: high flow nasal cannulaOxygen cannula or mask after extubation |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients mechanically ventilated for > 48 hours and at least one of the following:
- > 65 y/o
- Cardiac failure as the primary indication of mechanical ventilation
- COPD
- Bronchiectasis
Key exclusion criteria (4 listed)
- Presence of tracheostomy
- Recent facial trauma
- Active gastro-intestinal bleeding
- Planned NIPPV support after extubation
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 |
|---|---|---|
| high flow nasal cannulaAlso: Optiflow Airvo2 (Fisher & Paykel Healthcare)High flow nasal cannula used in postextubation patients | Device | high flow nasal cannula, stanrd oxygen therapy |
Primary outcome
reintubation rate
Time frame: 72 hours after extubation
12 secondary outcomes
Need for Non-Invasive Ventilation
Time frame: at day 28 after inclusion in the study
ICU readmission rate due to respiratory failure
Time frame: at day 28 after inclusion in the study
ICU mortality rate
Time frame: at day 28 after inclusion in the study
ICU length of stay
Time frame: at day 28 after inclusion in the study
Hospital mortality
Time frame: at day 28 after inclusion in the study
Hospital length of stay
Time frame: at day 28 after inclusion in the study
Nosocomial pneumonia rate
Time frame: at day 28 after inclusion in the study
Desaturation ( SaO2< 90%)
Time frame: 72 hours after extubation
Severe hypoxemia (PaO2/Fraction of inspired O2 < 200)
Time frame: Time Frame: 72 hours after extubation
hypercapnia (PaCO2 > 50)
Time frame: 72 hours after extubation
respiratory acidosis (arterial pH < 7.30)
Time frame: 72 hours after extubation
severe tachypnea (>40/min)
Time frame: 72 hours after extubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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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.
Kuo Li Kuo, MD principal investigator
+886975835135 lmn4093@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal cannula in people with Respiratory Failure and Congestive Heart Failure, run by Mackay Memorial Hospital at 1 site in Taiwan.
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 11 inclusion and 4 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 15 Dec 2014. 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 Taiwan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Contact Kuo li Kuo, MD (+886975835135, lmn4093@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reintubation rate (time frame: 72 hours after extubation). 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 15 Dec 2014.