Weaning From Mechanical Ventilation in Patients With Acute Brain Injury

NCT06542107 | Recruiting

• 1 other identifier: WEAN ABI
• Study Type: observational
• Target: 406
• Locations: 1 country
• Sites: 2

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.

Conditions

Ventilator Lung; Acute Brain Injury

Keywords

mechanical ventilation; acute brain injury; weaning

Outcome Measures

Primary Outcomes (1)

• weaning success

  successfully weaned from invasive ventilation according to WIND classification

  up to 7-day period (ICU stay)

Secondary Outcomes (1)

• extubation

  up to 7-day period (ICU stay)

Other Outcomes (1)

• tracheostomy

  up to 7-day period (ICU stay)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients admitted to the ICU due to acute brain injury and treated with invasive mechanical ventilation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Southeast University, China: lead

Study Sites (2)

Ling Liu

Nanjing, Jiangsu, 210009, China

RECRUITING

Department of Critical Care Medicine, Zhongda Hospital

Nanjing, China

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Ling Liu, PHD

CONTACT

86+83262553; liulingdoctor@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Intensive Care Unit, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: August 7, 2024
• Study Start: August 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

CN (2)