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

West China Hospital150 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

150

Conditions

Acute Hypoxic Respiratory Failure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: From the date when the patient meets the weaning screening criteria until the date of extubation, assessed up to 28 days.

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Other prognostic measures will be recorded until discharge, such as length of ICU stay and length of hospital stay in days.

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

Other prognostic measures will be recorded until discharge, such as 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

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.

Time frame: From date of enrollment until the date of transfer out of ICU, assessed up to 3 months.