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

S

Sichuan University

Status

Enrolling

Conditions

Acute Hypoxic Respiratory Failure

Treatments

Procedure: Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol
Procedure: The standard SBT guiding weaning group

Study type

Interventional

Funder types

Other

Identifiers

NCT06574659
Huaxi ICU-NVBT

Details and patient eligibility

About

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.

Full description

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

Enrollment

150 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Assigned Interventions
Experimental group
Description:
Noninvasive Ventilation Breathing Test guiding sequential invasive Ventilation and noninvasive ventilation weaning group with Ventilators.
Treatment:
Procedure: Noninvasive ventilation breathing test guiding sequential invasive Ventilation and noninvasive ventilation weaing protocol
The standard SBT guiding weaning group
Active Comparator group
Description:
The standard SBT guiding weaning protocol with Ventilators.
Treatment:
Procedure: The standard SBT guiding weaning group

Trial contacts and locations

1

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Central trial contact

Yongfang Zhou; Yan Kang

Data sourced from clinicaltrials.gov

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