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NCT Number: NCT06574659

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

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.

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Key information

Conditions

Acute Hypoxic Respiratory Failure

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol

Procedure

Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol

The standard SBT guiding weaning group

Procedure

The standard SBT guiding weaning protocol

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Collaborators

  • Dazhou Central Hospital
  • Sichuan University

Registry information

Official study title

Noninvasive Ventilation Breathing Test Guiding Sequential Invasive and Noninvasive Ventilation Weaning of Patients With Acute Hypoxic Respiratory Failure: a Randomized, Multicenter, Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 28, 2024
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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