Weaning From Mechanical Ventilation in Patients With Acute Brain Injury

Not yet recruiting

• Conditions: Acute Brain Injury; Ventilator Lung

• Registration Number: NCT06542107
• Lead Sponsor: Southeast University, China

Brief Summary

Acute brain injury (ABI) patients frequently necessate intubation and invasive mechanical ventilation (IMV). While some ABI patients are capable of breathing spontaneously, which is one of the main criteria of extubation and weaning. However, the rate of extubation failure was significantly higher in ABI patients compared with non-neurological critical care patients. In patients who have failed one or several trials of extubation, tracheostomy is recommend according to the latest ESICM consensus. Tracheostomy can enhance comfort, improve pulmonary hygiene and decrease sedation requirement, which could facilitate the liberation from ventilator.

Numerous studies have explored the causes of weaning failure and provide various predictive models in guiding extubation and tracheostomy. Yet, due to limitations of such as small sample size or a lack of external validation, there is paucity of practical weaning algorithm tailored for ABI patients. The liberation from IMV in ABI patients still remains challenging with poor level of evidence in current guidelines or expert consensus.

We aim to describe the weaning outcomes in ABI patients, and further investigate the potential predictors of weaning success in ABI patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-02
• Study Start: 2024-08-05
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-07
• Last Update Posted: 2024-08-07
• Primary Completion: 2025-07-31
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

• acute brain injury
• age >=18 years
• invasive mechanical ventilation for at least 24 hours

Exclusion Criteria

• tracheostomized before ICU admission
• pregnant or lactation
• with cervical spinal cord injury
• decision to receive palliative care within 24 hours of ICU admission

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
weaning success	up to 7-day period (ICU stay)	successfully weaned from invasive ventilation according to WIND classification

Secondary Outcome Measures

Name	Time	Method
extubation	up to 7-day period (ICU stay)	Extubation without the need for reintubation or death within a 7-day period, or upon ICU discharge, whichever occurs first

Trial Locations

Locations (1)

Ling Liu; 🇨🇳 Nanjing, Jiangsu, China