Noninvasive Ventilation Breathing Test Guiding Weaning in Patients With Acute Hypoxic Respiratory Failure

June 24, 2026 updated by: Kang Yan, West China Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All the patients included will be randomly assigned to receive Non Invasive Ventilation Breathing Test protocol or SBT protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yongfang Zhou
  • Phone Number: 86 18140212276
  • Email: zyfmg@163.com

Study Contact Backup

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital，Sichuan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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,
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Assigned Interventions
Noninvasive Ventilation Breathing Test guiding sequential invasive Ventilation and noninvasive ventilation weaning group with Ventilators.
Procedure: Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol
Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol
Active Comparator: The standard SBT guiding weaning group
The standard SBT guiding weaning protocol with Ventilators.
Procedure: The standard SBT guiding weaning group
The standard SBT guiding weaning protocol

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From the date when the patient meets the weaning screening criteria until the date of extubation, assessed up to 28 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Arterial blood gas analysis parameters at baseline, day 1, 3, and 7
Time Frame: From enrollment to Day 7.
Arterial blood gas analysis parameters are collected at baseline, Day 1, 3, and 7, such as arterial PaO2 in mmHg.
From enrollment to Day 7.
Respiratory parameters at baseline, day 1, 3, and 7
Time Frame: From enrollment to Day7.
Respiratory parameters are collected at baseline, Day 1, 3, and 7, such as airway plateau airway pressure in cmH2O.
From enrollment to Day7.
Hemodynamic parameters at baseline, day 1, 3, and 7
Time Frame: From enrollment to Day7
Hemodynamic parameters are collected at baseline, Day 1, 3, and 7, such as as blood pressure in mmHg.
From enrollment to Day7
Administration and quality of analgesia and sedation.
Time Frame: From enrollment until extubation, assessed up to 2 weeks.
Administration of analgesia and sedationare collected from enrollment to days 7, such as the analgesia and sedation in ug/kg/min.
From enrollment until extubation, assessed up to 2 weeks.
RASS scores
Time Frame: From enrollment until extubation, assessed up to 2 weeks.
The RASS score is assessed using a unique measurement method, and collected from enrollment to days 7.
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.
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.
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 prognostic measures will be recorded until discharge, such as length of ICU stay and length of hospital stay in days.
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.
Other prognostic measures will be recorded until discharge, such as ICU mortality and in-hospital mortality.
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.
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.
From date of enrollment until the date of transfer out of ICU, assessed up to 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
West China Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sichuan University
Dazhou Central Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Yan Kang, Department of Critical Care Medicine
  • Study Chair: Yongfang Zhou, Department of Respiratory Care
  • Principal Investigator: Xiaoyi Liu, Department of Critical Care Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 25, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Huaxi ICU-NVBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Any data collected during this study can be acquired from the corresponding author upon a reasonable request.

IPD Sharing Time Frame

Half a year after the publication of the research paper.

IPD Sharing Access Criteria

Any data collected during this study can be acquired from the corresponding author upon a reasonable request.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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