Patients With Acute Hypoxemic Respiratory FailureNCT03171935
Wean Early With HFNCO vs NPPV in Patients With AHRF
A study testing High-Flow Nasal Cannula Oxygenation, Noninvasive Positive Pressure Ventilation and Conventional weaning in people with Patients With Acute Hypoxemic Respiratory Failure, run by Beijing Chao Yang Hospital at 1 site in China.
Trial summary
The main purpose of the present study is to verify whether, as compared with conventional weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive pressure ventilation may more effective in shortening the duration of invasive ventilation, hence reducing the rates of complications and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Acute Hypoxemic Respiratory Failure
- What is being tested?
- High-Flow Nasal Cannula Oxygenation, Noninvasive Positive Pressure Ventilation and Conventional weaning
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2017to 31 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Orotracheal intubation；
- PaO2 <60mmHg（venturi mask，FiO2=0.5），and PaCO2 ≤45mmHg；
- Meeting criteria for weaning readiness；
- Spontaneous breathing trial failure.
Who cannot join
- Age<18；
- Duration of invasive ventilation <48h；
- Tracheotomy；
- Percentage of cuff leak volume in tidal volume<15.5%；
- Unable to spontaneously clear secretions from their airway；
- Recent oral，nasal，facial or cranial trauma or surgery；
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- Recent gastric or esophageal surgery；
- Active upper gastro-intestinal bleeding；
- Severe abdominal distension；
- Lack of co-operation；
- Chronic respiratory disease such as chronic obstructive pulmonary disease, asthma, interstitial lung disease and neuromuscular disease.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
Beijing
Zujin Luo, MD, 86-10-51718564, xmjg2002@163.com
About this study
Official title: Wean Early With High-Flow Nasal Cannula Oxygenation Versus Noninvasive Positive Pressure Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Multicenter, Randomized, Controlled Trial (the WHEN Study)
The main purpose of the present study is to verify whether, as compared with conventional weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive pressure ventilation may more effective in shortening the duration of invasive ventilation, hence reducing the rates of complications and mortality in patients with acute hypoxemic respiratory failure.
- Being tested
- High-Flow Nasal Cannula Oxygenation, Noninvasive Positive Pressure Ventilation, Conventional weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Cannula OxygenationDevice
High-flow nasal cannula oxygenation will be applied immediately after early extubation, with a gas flow rate of 50 liters per minute and a fraction of inspired oxygen of 1.0 at initiation. The fraction of inspired oxygen will be subsequently adjusted to maintain a peripheral oxygen saturation of 92% or more.
Noninvasive Positive Pressure VentilationDevice
Noninvasive positive pressure ventilation will be applied immediately after early extubation, with a noninvasive ventilator (Respironics V60, Philips) using the NIPSV mode at initiation. The fraction of inspired oxygen will be adjusted to achieve SpO2 >92% with an initial expiratory positive airway pressure (EPAP) of 4 cmH2O. EPAP will be increased gradually in increments of 1-2 cmH2O, up to a maximum of 12 cmH2O, to achieve SpO2 >96%. Inspiratory positive airway pressure (IPAP) will be initially set at 8 cmH2O and be increased gradually in increments of 1-2 cmH2O according to patients' tolerance to obtain a tidal volume (VT) of 6-8 mL/kg.
Conventional weaningDevice
The patients will undergo conventional weaning protocol. Extubation and subsequent oxygen therapy with venturi mask will be performed after successful spontaneous trial.
| Study group | Role | What they receive |
|---|---|---|
| High-Flow Nasal Cannula Oxygenation | Experimental | Not described Receives: Device: High-Flow Nasal Cannula Oxygenation |
| Noninvasive Positive Pressure Ventilation | Experimental | Not described Receives: Device: Noninvasive Positive Pressure Ventilation |
| Conventional Weaning | Active comparator | Not described Receives: Device: Conventional weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of invasive mechanical ventilation
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 Jun 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zujin Luo, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171935
- Sponsor's protocol ID
- BeijingCYH-ICU-005
- Status last verified
- Jun 2021
- First submitted
- 29 May 2017
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wean Early With High-Flow Nasal Cannula Oxygenation Versus Noninvasive Positive Pressure Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Multicenter, Randomized, Controlled Trial (the WHEN Study)
- ClinicalTrials.gov ID
- NCT03171935
- Acronym / sponsor ID
- BeijingCYH-ICU-005
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 31 May 2017 (actual)
- 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 main purpose of the present study is to verify whether, as compared with conventional weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive pressure ventilation may more effective in shortening the duration of invasive ventilation, hence reducing the rates of complications and mortality in patients with acute hypoxemic respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-Flow Nasal Cannula Oxygenation | Experimental | Device: High-Flow Nasal Cannula Oxygenation |
| Noninvasive Positive Pressure Ventilation | Experimental | Device: Noninvasive Positive Pressure Ventilation |
| Conventional Weaning | Active comparator | Device: Conventional weaning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Orotracheal intubation；
- PaO2 <60mmHg（venturi mask，FiO2=0.5），and PaCO2 ≤45mmHg；
- Meeting criteria for weaning readiness；
- Spontaneous breathing trial failure.
Key exclusion criteria (11 listed)
- Age<18；
- Duration of invasive ventilation <48h；
- Tracheotomy；
- Percentage of cuff leak volume in tidal volume<15.5%；
- Unable to spontaneously clear secretions from their airway；
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 Cannula OxygenationHigh-flow nasal cannula oxygenation will be applied immediately after early extubation, with a gas flow rate of 50 liters per minute and a fraction of inspired oxygen of 1.0 at initiation. The fraction of inspired oxygen will be subsequently adjusted to maintain a peripheral oxygen saturation of 92% or more. | Device | High-Flow Nasal Cannula Oxygenation |
| Noninvasive Positive Pressure VentilationNoninvasive positive pressure ventilation will be applied immediately after early extubation, with a noninvasive ventilator (Respironics V60, Philips) using the NIPSV mode at initiation. The fraction of inspired oxygen will be adjusted to achieve SpO2 >92% with an initial expiratory positive airway pressure (EPAP) of 4 cmH2O. EPAP will be increased gradually in increments of 1-2 cmH2O, up to a maximum of 12 cmH2O, to achieve SpO2 >96%. Inspiratory positive airway pressure (IPAP) will be initially set at 8 cmH2O and be increased gradually in increments of 1-2 cmH2O according to patients' tolerance to obtain a tidal volume (VT) of 6-8 mL/kg. | Device | Noninvasive Positive Pressure Ventilation |
| Conventional weaningThe patients will undergo conventional weaning protocol. Extubation and subsequent oxygen therapy with venturi mask will be performed after successful spontaneous trial. | Device | Conventional Weaning |
Primary outcome
Duration of invasive mechanical ventilation
Time frame: 2.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No
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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.
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 Oxygenation, Noninvasive Positive Pressure Ventilation and Conventional weaning in people with Patients With Acute Hypoxemic Respiratory Failure, run by Beijing Chao Yang Hospital at 1 site in China.
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 4 inclusion and 11 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 2 Jul 2021. 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 China. 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.
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 Zujin Luo, MD (10-86-51718564, xmjg2002@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of invasive mechanical ventilation (time frame: 2.5 years). 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 2 Jul 2021.