NCT07496125

Brief Summary

Invasive mechanical ventilation (IMV) is a life-saving supportive therapy for patients with acute brain injury, which accounted for nearly one-fifth of all mechanically ventilated patients in the intensive care unit (ICU). However, prolonged exposure to IMV is consistently associated with an increased risk of ventilator-related complications and adverse outcomes. Accordingly, alongside the initiation of IMV, timely and safe liberation from ventilator should be considered. Nevertheless, data detailing the weaning process and its associated outcomes in mechanically ventilated patients with ABI remain scarce. To address this gap, the investigators conducted an observational study aimed at characterizing the ventilator weaning process and outcomes in patients with ABI receiving IMV, using the modified WIND classification.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
Last Updated

June 8, 2026

Status Verified

June 1, 2026

Enrollment Period

8 years

First QC Date

March 22, 2026

Last Update Submit

June 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • weaning outcome

    The primary endpoint was the weaning outcome according to the modified WIND classification

    day 90

Study Arms (1)

Classified by weaning outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with ABI including traumatic brain injury (TBI), non-traumatic intracranial hemorrhage (ICH), subarachnoid aneurysmal hemorrhage (SAH), acute ischemic stroke (AIS), and central nervous system infection were eligible to this study, if they were ≥ 18 years old and underwent IMV for at least 24 hours

You may qualify if:

  • Patients with ABI
  • ≥ 18 years old
  • underwent IMV for at least 24 hours

You may not qualify if:

  • already tracheostomized
  • concurrent of cervical spinal cord injury
  • pregnant or lactation
  • withdraw of life-sustaining treatment within the first 24 hours of ICU admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Critical Care Medicine, Zhongda Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries
0

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD & MD

Study Record Dates

First Submitted

March 22, 2026

First Posted

March 27, 2026

Study Start

January 1, 2018

Primary Completion

December 31, 2025

Study Completion

March 1, 2026

Last Updated

June 8, 2026

Record last verified: 2026-06

Locations