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Study identifier: NCT06667869 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

multipaRameter mOnitoring systeM for sedAtion iNThe ICu

Condition: Sedation Complication  ·  Sponsor: Pontificia Universidad Catolica de Chile

PhaseN/A
Planned participants80
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The administration of sedation in Intensive Care Units (ICU) is a vital and complex task, essential for the well-being of critically ill patients. Proper dosing is crucial, as both under-dosing and overdosing have adverse consequences for patients, including risks such as accidental extubation, ventilator disconnections, delirium, prolonged ventilation, ICU stays, and even increased mortality. Monitoring sedation levels is essential to maintain a balance in sedative administration. Clinical scales (RASS/SAS) are currently used as the reference method, but they have limitations. These scales may be inadequate when the patient is unresponsive or when neuromuscular blockers are used. An alternative is electroencephalography (EEG)-based monitors, though they also have limitations in accurately representing the level of hypnosis. The proposal is to develop an advanced multiparameter system called ROMANTIC, which utilizes machine learning algorithms to monitor sedation status continuously. The aim is for this system to surpass current techniques and provide a more accurate determination of sedation levels. ROMANTIC would incorporate a variety of variables, demographic, pharmacological, hemodynamic, respiratory, and EEG data, to predict sedation status in three categories: under-dosing, appropriate dosing, and overdosing. With ROMANTIC, clinical staff (users) are expected to be able to determine sedation levels more quickly and accurately, reducing patients' wake-up times and pos…

This description comes directly from the study's public registry record.

Talk to the study team

Juan C. Pedemonte, M.D.  ·  +56 99 879 8836  ·  jcpedemo@uc.cl

Always discuss trial participation with your own doctor first.

Locations (2)

Hospital Dr. Sotero del RioSantiago, Metropolitana de Santiago, ChileNot Yet Recruiting
Hospital Clínico Pontificia Universidad Católica de ChileSantiago, Santiago Metropolitan, ChileRecruiting

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Source record: clinicaltrials.gov/study/NCT06667869