Acute Hypoxic Respiratory FailureNCT06574659
Noninvasive Ventilation Breathing Test Guiding Weaning in Patients With Acute Hypoxic Respiratory Failure
A study testing Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol and The standard SBT guiding weaning group in people with Acute Hypoxic Respiratory Failure, run by West China Hospital at 1 site in China.
Trial summary
SBT, as a routine extubation strategy for invasive mechanical ventilation, has been widely recognized. However, in recent years, studies have found that SBT may lead to delayed extubation, which has been confirmed in COPD patients but has not yet been widely accepted in patients with acute hypoxic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Hypoxic Respiratory Failure
- What is being tested?
- Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol and The standard SBT guiding weaning group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2024to 20 Mar 2025
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who have been admitted to the intensive care unit (ICU) with Acute Hypoxic Respiratory Failure. Oxygenation index less than 300mmHg, have undergone tracheal intubation, and are anticipated received invasive mechanical ventilation for more than 24 hours.
Who cannot join
- • Age over 80 years,
- Pregnancy,
- Consciousness disorders or intracranial hypertension caused by various reasons,
- Neuromuscular disorders,
- Severe cardiac dysfunction (New York Heart Association Class III or IV, acute coronary syndrome or persistent ventricular tachycardia),
- Cardiogenic shock or after major cardiac surgery,
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- Severe liver and kidney failure,
- Severe malnutrition,
- Injury to the upper airway or nose and face, making it impossible to wear a nose (face) mask,
- Severe agitation, Severe agitation, expected to be unable to cooperate with non-invasive mechanical ventilation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Ventilation Breathing Test Guiding Sequential Invasive and Noninvasive Ventilation Weaning of Patients With Acute Hypoxic Respiratory Failure: a Randomized, Multicenter, Controlled Trial
SBT, as a routine extubation strategy for invasive mechanical ventilation, has been widely recognized. However, in recent years, studies have found that SBT may lead to delayed extubation, which has been confirmed in COPD patients but has not yet been widely accepted in patients with acute hypoxic respiratory failure. Both invasive mechanical ventilation and non-invasive mechanical ventilation are positive pressure ventilation, with the essential difference being the human-machine interface. The safe inspiratory pressure for non-invasive mechanical ventilation should not exceed 20cmH2O (1cmH2O=0.098 kPa). If the cause of respiratory failure is relieved or removed, respiratory function improves, and the patient has good airway protection ability and can tolerate non-invasive ventilation, the endotracheal tube can be removed as soon as possible to switch to non-invasive mechanical ventilation, thereby shortening the time of invasive mechanical ventilation and reducing the risk of complications. This study trial aims to identify the timing of early extubation sequential non-invasive mechanical ventilation in patients with acute hypoxic respiratory failure through non-invasive ventilation breathing tests, providing a basis for updating the process of invasive mechanical ventilation extubation.
Read the detailed description
All the patients included will be randomly assigned to receive Non Invasive Ventilation Breathing Test protocol or SBT protocol.
- Conditions
- Acute Hypoxic Respiratory Failure
- Being tested
- Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol, The standard SBT guiding weaning group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocolProcedure or surgery
Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol
The standard SBT guiding weaning groupProcedure or surgery
The standard SBT guiding weaning protocol
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | Noninvasive Ventilation Breathing Test guiding sequential invasive Ventilation and noninvasive ventilation weaning group with Ventilators. Receives: Procedure: Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol |
| The standard SBT guiding weaning group | Active comparator | The standard SBT guiding weaning protocol with Ventilators. Receives: Procedure: The standard SBT guiding weaning group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weaning time
Weaning time in hours is defined as the time period from the date when the patient meets the weaning screening criteria until the date of extubation.
Measured: From the date when the patient meets the weaning screening criteria until the date of extubation, assessed up to 28 days.
Secondary outcomes (9)
Arterial blood gas analysis parameters at baseline, day 1, 3, and 7
Arterial blood gas analysis parameters are collected at baseline, Day 1, 3, and 7, such as arterial PaO2 in mmHg.
Measured: From enrollment to Day 7.
Respiratory parameters at baseline, day 1, 3, and 7
Respiratory parameters are collected at baseline, Day 1, 3, and 7, such as airway plateau airway pressure in cmH2O.
Measured: From enrollment to Day7.
Hemodynamic parameters at baseline, day 1, 3, and 7
Hemodynamic parameters are collected at baseline, Day 1, 3, and 7, such as as blood pressure in mmHg.
Measured: From enrollment to Day7
Administration and quality of analgesia and sedation.
Administration of analgesia and sedationare collected from enrollment to days 7, such as the analgesia and sedation in ug/kg/min.
Measured: From enrollment until extubation, assessed up to 2 weeks.
RASS scores
The RASS score is assessed using a unique measurement method, and collected from enrollment to days 7.
Measured: From enrollment until extubation, assessed up to 2 weeks.
EIT data
Obtain EIT data for before SBT and during SBT, and during non-invasive mechanical ventilation or nasal high flow ventilation after extubation with EIT, including pulmonary ventilation indicators such as Global TV in ml.
Measured: From the time when patients are ready for SBT trial until 1h after extubation, assessed up to 1 week.
Other outcomes: length of ICU stay and length of hospital stay
Other prognostic measures will be recorded until discharge, such as length of ICU stay and length of hospital stay in days.
Measured: From the date of enrollment until the date of discharge, assessed up to 1 year.
Other outcomes: ICU mortality and in-hospital mortality
Other prognostic measures will be recorded until discharge, such as ICU mortality and in-hospital mortality.
Measured: From the date of enrollment until the date of discharge, assessed up to 1 year.
Adverse events
Adverse events will be recorded from enrollment until transfer out of ICU, include the occurence rate of barotrauma, ventilator-associated pneumonia，delirium, and pressure injury on the face.
Measured: From date of enrollment until the date of transfer out of ICU, assessed up to 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start25 Aug 2024
- Primary completion20 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxic Respiratory FailureStudies of the same condition, open and under way.
- More trials run by West China 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sichuan University, Dazhou Central Hospital
- Responsible party
- Principal investigator, Kang Yan, West China Hospital
- Investigators
- Yan Kang, Study chair, Department of Critical Care MedicineYongfang Zhou, Study chair, Department of Respiratory CareXiaoyi Liu, Principal investigator, Department of Critical Care Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574659
- Sponsor's protocol ID
- Huaxi ICU-NVBT
- Status last verified
- Jun 2026
- First submitted
- 17 Jul 2024
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any data collected during this study can be acquired from the corresponding author upon a reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Ventilation Breathing Test Guiding Sequential Invasive and Noninvasive Ventilation Weaning of Patients With Acute Hypoxic Respiratory Failure: a Randomized, Multicenter, Controlled Trial
- ClinicalTrials.gov ID
- NCT06574659
- Acronym / sponsor ID
- Huaxi ICU-NVBT
- Conditions
- Acute Hypoxic Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- Sichuan University, Dazhou Central Hospital
- Study start
- 25 Aug 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 28 Aug 2024 (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.
SBT, as a routine extubation strategy for invasive mechanical ventilation, has been widely recognized. However, in recent years, studies have found that SBT may lead to delayed extubation, which has been confirmed in COPD patients but has not yet been widely accepted in patients with acute hypoxic respiratory failure. Both invasive mechanical ventilation and non-invasive mechanical ventilation are positive pressure ventilation, with the essential difference being the human-machine interface. The safe inspiratory pressure for non-invasive mechanical ventilation should not exceed 20cmH2O (1cmH2O=0.098 kPa). If the cause of respiratory failure is relieved or removed, respiratory function improves, and the patient has good airway protection ability and can tolerate non-invasive ventilation, the endotracheal tube can be removed as soon as possible to switch to non-invasive mechanical ventilation, thereby shortening the time of invasive mechanical ventilation and reducing the risk of complications. This study trial aims to identify the timing of early extubation sequential non-invasive mechanical ventilation in patients with acute hypoxic respiratory failure through non-invasive ventilation breathing tests, providing a basis for updating the process of invasive mechanical ventilation extubation.
Detailed description
All the patients included will be randomly assigned to receive Non Invasive Ventilation Breathing Test protocol or SBT protocol.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Procedure: Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocolNoninvasive Ventilation Breathing Test guiding sequential invasive Ventilation and noninvasive ventilation weaning group with Ventilators. |
| The standard SBT guiding weaning group | Active comparator | Procedure: The standard SBT guiding weaning groupThe standard SBT guiding weaning protocol with Ventilators. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who have been admitted to the intensive care unit (ICU) with Acute Hypoxic Respiratory Failure. Oxygenation index less than 300mmHg, have undergone tracheal intubation, and are anticipated received invasive mechanical ventilation for more than 24 hours.
Key exclusion criteria (10 listed)
- • Age over 80 years,
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 |
|---|---|---|
| Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocolNoninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol | Procedure or surgery | Assigned Interventions |
| The standard SBT guiding weaning groupThe standard SBT guiding weaning protocol | Procedure or surgery | The standard SBT guiding weaning group |
Primary outcome
Weaning time
Time frame: From the date when the patient meets the weaning screening criteria until the date of extubation, assessed up to 28 days.
Weaning time in hours is defined as the time period from the date when the patient meets the weaning screening criteria until the date of extubation.
9 secondary outcomes
Arterial blood gas analysis parameters at baseline, day 1, 3, and 7
Time frame: From enrollment to Day 7.
Respiratory parameters at baseline, day 1, 3, and 7
Time frame: From enrollment to Day7.
Hemodynamic parameters at baseline, day 1, 3, and 7
Time frame: From enrollment to Day7
Administration and quality of analgesia and sedation.
Time frame: From enrollment until extubation, assessed up to 2 weeks.
RASS scores
Time frame: From enrollment until extubation, assessed up to 2 weeks.
EIT data
Time frame: From the time when patients are ready for SBT trial until 1h after extubation, assessed up to 1 week.
Other outcomes: length of ICU stay and length of hospital stay
Time frame: From the date of enrollment until the date of discharge, assessed up to 1 year.
Other outcomes: ICU mortality and in-hospital mortality
Time frame: From the date of enrollment until the date of discharge, assessed up to 1 year.
Adverse events
Time frame: From date of enrollment until the date of transfer out of ICU, assessed up to 3 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Yes. Any data collected during this study can be acquired from the corresponding author upon a reasonable request.
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ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
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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.
Yan Kang study chair
Department of Critical Care Medicine
Yongfang Zhou study chair
Department of Respiratory Care
Xiaoyi Liu principal investigator
Department of Critical Care Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol and The standard SBT guiding weaning group in people with Acute Hypoxic Respiratory Failure, run by West China 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 29 Jun 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weaning time (time frame: From the date when the patient meets the weaning screening criteria until the date of extubation, assessed 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 29 Jun 2026.