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

NCT06574659 | Recruiting DMC

• 1 other identifier: Huaxi ICU-NVBT
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Hypoxic Respiratory Failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Arterial blood gas analysis parameters at baseline, day 1, 3, and 7

  From enrollment to Day 7.

• Respiratory parameters at baseline, day 1, 3, and 7

  From enrollment to Day7.

• Hemodynamic parameters at baseline, day 1, 3, and 7

  From enrollment to Day7

• Administration and quality of analgesia and sedation.

  From enrollment until extubation, assessed up to 2 weeks.

• RASS scores

  From enrollment until extubation, assessed up to 2 weeks.

Study Arms (2)

Assigned Interventions

EXPERIMENTAL

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

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

The standard SBT guiding weaning group

ACTIVE COMPARATOR

The standard SBT guiding weaning protocol with Ventilators.

Procedure: The standard SBT guiding weaning group

Interventions

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

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

Assigned Interventions

The standard SBT guiding weaning group PROCEDURE

The standard SBT guiding weaning protocol

The standard SBT guiding weaning group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead
• Sichuan University: collaborator
• Dazhou Central Hospital: collaborator

Study Sites (1)

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

Study Officials

• Yan Kang

  Department of Critical Care Medicine

  STUDY CHAIR

• Yongfang Zhou

  Department of Respiratory Care

  STUDY CHAIR

• Xiaoyi Liu

  Department of Critical Care Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongfang Zhou

CONTACT

86 18140212276; zyfmg@163.com

Yan Kang

CONTACT

86 18980601566; kang_yan_123@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Chair of West China of Tian Hoapital

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: August 28, 2024
• Study Start: March 20, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Half a year after the publication of the research paper.
• Access Criteria: Any data collected during this study can be acquired from the corresponding author upon a reasonable request.

Locations

CN (1)