Mapping the waking brain: how ICU patients emerge from sedation
NCT ID NCT07710066
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This observational study tracks how critically ill patients on breathing machines regain consciousness after sedation is reduced or stopped. Researchers will monitor patients for 72 hours to identify different patterns of recovery and see if those patterns relate to outcomes like time on the ventilator, delirium, and long-term recovery. The goal is to better understand this early waking phase, which is not well captured by current medical classifications.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 500 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Consecutive adult critically ill patients receiving invasive mechanical ventilation for at least 24 hours who undergo a first valid Structured Awakening Evaluation (SAE) following continuous analgosedation during their ICU stay. The study focuses on patients without acute primary structural brain injury or active neuroprotective sedation, in whom recovery of consciousness, ventilator liberation, and subsequent clinical and patient-centered outcomes can be prospectively characterized.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Adult critically ill patients with acute respiratory failure or requiring invasive mechanical ventilation in the context of critical illness will be consecutively enrolled. Eligible participants must meet all of the following criteria: * Age ≥18 years. * Receiving invasive mechanical ventilation for ≥24 hours. * Prior exposure to continuous analgosedation before undergoing a first valid Structured Awakening Evaluation (SAE) during the ICU stay, as defined by the study's operational criteria. * Availability of sufficient clinical information to identify the baseline time point (t0) and characterize the first valid Structured Awakening Evaluation according to the study's operational definitions. * Provision of informed consent for participation in the study. Exclusion Criteria: 1. Acute primary structural brain injury in which the level of consciousness is primarily determined by the neurological condition or constitutes a therapeutic target, including but not limited to: * Moderate or severe traumatic brain injury. * Subarachnoid hemorrhage. * Ischemic or hemorrhagic stroke. * Central nervous system infections. * Other structural brain injuries requiring therapeutic sedation or goal-directed intensive neurological monitoring. 2. Ongoing therapeutic sedation for neurological indications at the time of the first valid Structured Awakening Evaluation (SAE), including: * Intracranial hypertension management. * Status epilepticus. * Other neuroprotective strategies requiring deep sedation. 3. ICU admission following cardiac arrest with return of spontaneous circulation and suspected hypoxic-ischemic brain injury or the need for targeted therapeutic sedation. 4. Insufficient clinical information to accurately identify the baseline time point (t0) and characterize the architecture of the first valid Structured Awakening Evaluation. 5. Patients receiving extracorporeal life support (ECLS/ECMO), in whom assessment of hemodynamic and respiratory stability before initiation of awakening and liberation from invasive mechanical ventilation is substantially more complex.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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