Ceribell Delirium Monitor Outcomes Pilot Study
ConditionDelirium in the Intensive Care Unit
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCeribell Inc.
About this trial
This pilot study is designed as a pre- and post-delirium monitor cohort study, with a prospective intervention cohort and a retrospective control cohort.
Eligibility criteria
Qualifiers
Age is 18 years or older
Admitted to the ICU for an expected duration ≥ 24 hours from enrollment
Disqualifiers
Baseline neurological dysfunction (Glasgow Coma Scale < 10) and pre-existing brain injuries such as stroke with known deficits, severe TBI
History of moderate-severe dementia (IQCODE ≥ 3.5)
APACHE II score > 30, or SOFA > 9 at enrollment
Trial design
Treatments tested in this trial
- Ceribell Delirium Monitoring System
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov