multipaRameter mOnitoring systeM for sedAtion iNThe ICu
Launched by PONTIFICIA UNIVERSIDAD CATOLICA DE CHILE · Oct 30, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called ROMANTIC, is studying a new system designed to monitor sedation levels in patients who are critically ill and in Intensive Care Units (ICUs). Proper sedation is crucial for these patients, as both too little and too much sedation can lead to serious complications, such as longer recovery times and even increased risk of death. The goal of the trial is to develop an advanced monitoring system that uses machine learning to provide more accurate and continuous assessments of sedation levels. This could help healthcare providers give the right amount of sedation more quickly, potentially reducing complications like delirium and the time patients spend on mechanical ventilation.
To be eligible for this trial, participants must be adults over 18 who are admitted to an ICU and require sedation and mechanical ventilation for more than 24 hours. Certain conditions, like pregnancy or specific neurological issues, may exclude individuals from participating. If you or a loved one qualify for this trial, you can expect to be part of a study that aims to improve how sedation is managed, potentially leading to better outcomes and shorter ICU stays for critically ill patients.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients admitted to adult critical care units
- • Individuals over 18 years old
- • Requiring sedation for more than 24 hours
- • Patients needing mechanical ventilation for more than 24 hours
- Exclusion Criteria:
- • Patients with neurological pathology as the cause of mechanical ventilation (including recovered cardiocirculatory arrest, fulminant liver failure, and neurocritical conditions, except subdural hematomas or subarachnoid hemorrhages).
- • Pregnancy
- • Presence of psychiatric or intellectual disability prior to hospitalization
- • Drug dependency
- • History of chronic liver damage with hepatic encephalopathy
- • Second period of mechanical ventilation during hospitalization
- • Early limitation of therapeutic effort
- • Patients under 18 years old
About Pontificia Universidad Catolica De Chile
Pontificia Universidad Católica de Chile is a prestigious academic institution renowned for its commitment to excellence in education, research, and healthcare. As a clinical trial sponsor, the university leverages its extensive expertise in medical sciences to advance innovative research initiatives aimed at improving patient outcomes. With a strong emphasis on ethical standards and scientific rigor, the institution collaborates with multidisciplinary teams to conduct high-quality clinical trials that contribute to the advancement of medical knowledge and the development of effective therapeutic interventions. Its dedication to fostering a culture of inquiry and community engagement positions Pontificia Universidad Católica de Chile as a leader in the field of clinical research in Latin America.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Santiago, Región Metropolitana, Chile
Santiago, Metropolitana De Santiago, Chile
Santiago, , Chile
Patients applied
Trial Officials
Juan C. Pedemonte, M.D.
Study Director
Pontificia Universidad Catolica de Chile
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported