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

NCT ID: NCT06574659

Last Updated: 2024-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2024-12-30

Brief Summary

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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

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

Conditions

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Acute Hypoxic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Assigned Interventions

Noninvasive Ventilation Breathing Test guiding sequential invasive Ventilation and noninvasive ventilation weaning group with Ventilators.

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

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

The standard SBT guiding weaning group

The standard SBT guiding weaning protocol with Ventilators.

Group Type ACTIVE_COMPARATOR

The standard SBT guiding weaning group

Intervention Type PROCEDURE

The standard SBT guiding weaning protocol

Interventions

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

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

Intervention Type PROCEDURE

The standard SBT guiding weaning group

The standard SBT guiding weaning protocol

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan University

OTHER

Sponsor Role collaborator

Dazhou Central Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kang Yan

The Chair of West China of Tian Hoapital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yan Kang

Role: STUDY_CHAIR

Department of Critical Care Medicine

Yongfang Zhou

Role: STUDY_CHAIR

Department of Respiratory Care

Xiaoyi Liu

Role: PRINCIPAL_INVESTIGATOR

Department of Critical Care Medicine

Locations

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West China Hospital,Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yongfang Zhou

Role: CONTACT

86 18140212276

Yan Kang

Role: CONTACT

86 18980601566

Facility Contacts

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Yan Kang

Role: primary

86-18980601566

Yongfang Zhou

Role: backup

86-18980606418

Other Identifiers

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Huaxi ICU-NVBT

Identifier Type: -

Identifier Source: org_study_id

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