Clinical trial · Interventional
The NEUROlogically-impaired Extubation Timing Trial
NCT02920580CI-TRIAL-00043207NEURO-ETTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This randomized controlled trial will enrol patients with acute severe brain injury who pass a spontaneous breathing trial but have decreased level of consciousness. It will directly compare (1) prompt extubation vs. (2) usual care, with extubation or tracheostomy timed according to physicians' discretion. The primary outcome will be ICU free days (days spent alive and outside an ICU).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Brain Injury | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Extubation | Procedure | — | UNRESOLVED |
| Usual Care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Extubation
- description
- Extubation by removal of endotracheal tube.
- interventionNames
- Procedure: Extubation
- type
- ACTIVE_COMPARATOR
- label
- Usual care
- description
- The usual clinical practice is removal of the endotracheal tube (extubation), or insertion of tracheostomy, timed according to physicians' discretion
- interventionNames
- Procedure: Usual Care
Primary outcomes (1)
- measure
- ICU Free Days
- timeFrame
- 60 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 16 years * Acute brain injury (subarachnoid hemorrhage, ischemic stroke, spontaneous intracerebral hemorrhage, seizure, traumatic brain injury, brain tumor, global cerebral anoxia/cardiac arrest, meningitis/encephalitis/cerebral abscess) that occurred within the previous 4 weeks. * Receiving invasive mechanical ventilation via endotracheal tube for \> 72 hours * Glasgow Coma Scale motor score 3 to 6 with improvement or no change from previous day * passed spontaneous breathing trial (SBT) Exclusion Criteria: * Previous extubation during this ICU admission * Quadriplegic * Neuromuscular disease that will result in prolong need for mechanical ventilation, including but not limited to Guillain-Barre syndrome, cervical spinal cord injury, advanced multiple sclerosis * Do-Not-Reintubate order in place * Previously randomized in this trial * Underlying pre-existing condition with expected mortality less than 6-months. * Anticipated/scheduled for surgical procedures within 48 hours * C-spine not yet cleared for activity as tolerated (cleared for activity as tolerated while wearing hard collar is acceptable) * Currently known or suspected to have an difficult airway * Absence of an endotracheal tube cuff leak, if checked * Absence of spontaneous or induced cough * Current enrolment in an RCT that precludes NEURO-ETT co-enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.