Noninvasive Ventilation Breathing Test Guiding Weaning in Patients With Acute Hypoxic Respiratory Failure
NCT Number: NCT06574659
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Acute Hypoxic Respiratory Failure
Interventions: PROCEDURE: Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol|PROCEDURE: The standard SBT guiding weaning group
Sponsor: West China Hospital
Collaborators: Sichuan University|Dazhou Central Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-03-20
Completion Date: 2024-12-30
Locations: West China Hospital,Sichuan University, Chengdu, Sichuan, 610041, China

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. 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.

Primary Outcome Measures: 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: 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.