Clinical trial NCT06574659: Noninvasive Ventilation Breathing Test Guiding Weaning in Patients With Acute Hypoxic Respiratory Failure
Official title: Noninvasive Ventilation Breathing Test Guiding Sequential Invasive and Noninvasive Ventilation Weaning of Patients With Acute Hypoxic Respiratory Failure: a Randomized, Multicenter, Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxic Respiratory Failure
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: Sichuan University
name: Dazhou Central Hospital
First posted: 2024-08-28
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Weaning time
timeFrame: From the date when the patient meets the weaning screening criteria until the date of extubation, assessed up to 28 days.
Secondary outcomes:
measure: Arterial blood gas analysis parameters at baseline, day 1, 3, and 7
timeFrame: From enrollment to Day 7.
measure: Respiratory parameters at baseline, day 1, 3, and 7
timeFrame: From enrollment to Day7.
measure: Hemodynamic parameters at baseline, day 1, 3, and 7
timeFrame: From enrollment to Day7
measure: Administration and quality of analgesia and sedation.
timeFrame: From enrollment until extubation, assessed up to 2 weeks.
measure: RASS scores
timeFrame: From enrollment until extubation, assessed up to 2 weeks.
measure: EIT data
timeFrame: From the time when patients are ready for SBT trial until 1h after extubation, assessed up to 1 week.
measure: Other outcomes: length of ICU stay and length of hospital stay
timeFrame: From the date of enrollment until the date of discharge, assessed up to 1 year.
measure: Other outcomes: ICU mortality and in-hospital mortality
timeFrame: From the date of enrollment until the date of discharge, assessed up to 1 year.
measure: Adverse events
timeFrame: From date of enrollment until the date of transfer out of ICU, assessed up to 3 months.
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital,Sichuan University
state: Sichuan
Study officials:
affiliation: Department of Critical Care Medicine
name: Yan Kang
role: STUDY_CHAIR
affiliation: Department of Respiratory Care
name: Yongfang Zhou
role: STUDY_CHAIR
affiliation: Department of Critical Care Medicine
name: Xiaoyi Liu
role: PRINCIPAL_INVESTIGATOR
References: