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

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: Completed
• Conditions: Acute Hypoxic Respiratory Failure
• Intervention / Treatment: Procedure: Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol; Procedure: The standard SBT guiding weaning group

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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.	From the date when the patient meets the weaning screening criteria until the date of extubation, assessed up to 28 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	From date of enrollment until the date of transfer out of ICU, assessed up to 3 months.

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: Sichuan University; Dazhou Central Hospital
• Investigators: 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

Study Major Dates

• Study Start (Actual): August 3, 2024
• Primary Completion (Actual): March 20, 2025
• Study Completion (Actual): March 20, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoxia
• Other Study ID 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