multipaRameter mOnitoring systeM for sedAtion iNThe ICu (ROMANTIC)

June 4, 2025 updated by: Pontificia Universidad Catolica de Chile

Sistema de monitorización multiparámetros Para sedación de Pacientes críticos en UCI (ROMANTIC: multipaRameter mOnitoring systeM for sedAtion iNThe ICu)

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 possibly decreasing the incidence of delirium. In the long term, this could result in fewer ICU bed days, less time on mechanical ventilation, cost savings, and reduced complications.

At the end of the project, the goal is to have a prototype model or software that allows non-specialized staff (users) to quickly determine sedation levels in the ICU. This machine learning-based model targets hospitals with ICUs and mechanical ventilation to offer more efficient and cost-effective clinical care. ROMANTIC seeks to innovate in sedation monitoring, providing a more advanced and precise tool for the care of critically ill patients (beneficiaries) in the ICU.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The project is characterized by incorporating multiple clinical, demographic, and pharmacological variables, along with prediction methods based on machine learning, to classify the level of sedation of critically ill patients into three broad categories: underdosage, appropriate dosage, and overdosage. The investigators will compare the performance of this approach against the current gold standard, which is the use of validated clinical sedation scales (RASS/SAS).

The design of this project is divided into two phases. The first phase involves a prospective observational cohort study where demographic, vital signs, ventilatory, pharmacological, and EEG variables will be collected from ICU patients. The second phase involves using the data obtained to create a multiparameter model with machine learning tools that informs ICU staff about the depth of sedation or the degree of hypnosis of each patient. Data will be collected from two national intensive care units: Hospital Clinico Red UC-CHRISTUS (associated entity) and Dr. Sótero del Río Hospital (associated entity). A technical team specialized in data collection and analysis, clinical research, and algorithm development from Pontificia Universidad Católica de Chile (beneficiary entity) will use this information to create a retrospective classifier that categorizes patients into one of three groups: underdosed, appropriately dosed, and overdosed.

Upon admission, comprehensive patient data will be collected, including age, sex, cause of connection to mechanical ventilation, comorbidities, and educational level. The researchers will also record the drugs and doses used for sedation, neuromuscular relaxants, and vasopressor drugs. Sedation will be administered with Fentanyl plus Propofol or Midazolam, according to usual clinical practices at both participating centers. Data from the RASS and SAS clinical sedation rating scales will be collected every hour during two time windows, providing a detailed picture of the patient's sedation levels.

There will be two or three data recording windows per patient. Time zero will be when the patient is intubated and connected to mechanical ventilation. The first collection window will be between 18 to 60 hours after intubation, for a period of 6 hours during business hours, aiming to obtain a record of data once the chosen sedation strategy is established and has presumably stable blood levels of drugs. The second window will start once the patient's sedation is suspended and will last for at least 6 hours or until the patient awakens, defined as SAS 4 and RASS 0, with eyes open to verbal command or if the patient presents agitation and/or delirium according to CAM-ICU. The suspension time will be recorded, along with the day and time all sedatives are stopped in the continuous infusion pump. If for any reason it is necessary to sedate the patient again, a third window similar to the second will be performed.

Demographic (age, previous educational level, SOFA, Charlson, APACHE II), hemodynamic (systolic and diastolic blood pressure, heart rate, electrocardiography), ventilatory (oxygen saturation, respiratory rate, ventilatory mode, PEEP, tidal volume, plateau pressure, peak pressure), electroencephalographic (EEG signal in time domain), pain (hourly behavioral pain scale), neuromuscular blockade (hourly TOF), and pharmacological (total mass of sedative drugs used at the time of suspending infusions and plasma samples of sedative drug concentration at the beginning of both windows) data will be collected. Once patients wake up, the onset of delirium will be assessed with the CAM-ICU tool twice a day (AM/PM) by appropriately trained nursing staff.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Juan C. Pedemonte, M.D.
  • Phone Number: +56 99 879 8836
  • Email: jcpedemo@uc.cl

Study Locations

  • Chile
    • Metropolitana de Santiago
      • Santiago, Metropolitana de Santiago, Chile, 7700642
    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile, 8330024
        • Recruiting
        • Hospital Clínico Pontificia Universidad Católica de Chile
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients admitted to intensive care units requiring sedation and mechanical ventilation for more than 24 hours.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hospital Clínico Red de Salud UC-Christus
Adult patients admitted to intensive care units at Hospital Clinico Red de Salud UC-Christus who require sedation and mechanical ventilation for more than 24 hours.
Drug: Sedative
Patients admitted to intensive care units who require sedation and mechanical ventilation for more than 24 hours.
Other Names:
  • Mechanical ventilation
Hospital Dr. Sotero del Rio
Adult patients admitted to intensive care units at Hospital Dr. Sotero del Rio who require sedation and mechanical ventilation for more than 24 hours.
Drug: Sedative
Patients admitted to intensive care units who require sedation and mechanical ventilation for more than 24 hours.
Other Names:
  • Mechanical ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to extubation
Time Frame: From the start of last window up to extubation (assessed up to 72 hours)
Time elapsed from the stop of sedative drugs to extubation (assessed up to 72 hours)
From the start of last window up to extubation (assessed up to 72 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Intensive Care Unit stay
Time Frame: During intensive care unit hospitalization (assessed up to 100 days)
Time (assessed up to 100 days) elapsed from admission to discharge from intensive care unit
During intensive care unit hospitalization (assessed up to 100 days)
Length of mechanical ventilation
Time Frame: During intensive care unit hospitalization (assessed up to 100 days)
Time (assessed up to 100 days) elapsed from intubation to extubation
During intensive care unit hospitalization (assessed up to 100 days)
Intensive Care Unit Delirium incidence
Time Frame: From extubation to discharge from Intensive Care Unit, CAM-ICU assessed twice daily (AM/PM) for the first 5 post extubation days
Positive Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)
From extubation to discharge from Intensive Care Unit, CAM-ICU assessed twice daily (AM/PM) for the first 5 post extubation days
Serum concentration of sedative drugs
Time Frame: At baseline of all data extraction windows (assessed at the first hour of the respective window)
Quantification of serum concentration of sedative drugs (Midazolam, Propofol, Fentanyl)
At baseline of all data extraction windows (assessed at the first hour of the respective window)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Collaborators

Agencia Nacional de Investigacion y Desarrollo, ANID

Investigators

  • Study Director: Juan C. Pedemonte, M.D., Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

September 30, 2024

First Submitted That Met QC Criteria

October 30, 2024

First Posted (Actual)

October 31, 2024

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230926014
  • FONDEF ID24I10057 (Other Grant/Funding Number: Agencia Nacional de Investigación y Desarrollo)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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