Clinical Performance of the Automated Closed-loop Minimum Viable Prototype

Deep Sedation Clinical Trial

Official title:

Clinical Performance of a Minimum Viable Prototype for Automated Closed-Loop Administration of Propofol for Deep Sedation in Patients on Invasive Mechanical Ventilation in Critically Ill Patient Units: a Pilot Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187545
• Other study ID #: 1219/21
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: University of Chile
• Contact: Antonello Penna, MD, PhD
• Phone: +56229788209
• Email: apenna[@]uchile.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to evaluate a minimum viable prototype for automated closed-loop administration of propofol in deep sedated patients under invasive mechanical ventilation in the ICU. The main question it aims to answer is: • whether the minimum viable prototype for automated closed-loop administration of propofol is effective in keeping patients in deep sedation using the lowest possible dose of propofol Participants will undergo deep sedation using the minimum viable prototype for automated closed-loop propofol administration. The usual practice of sedation will be compared with the practice of sedating with the minimum viable prototype to see if the infusion rate of propofol is decreased

Description:

The design of the study will consist of each patient being exposed to both forms of administration (matched pair study) during a 12-hour day (8:00 a.m. to 8:00 p.m.) in a randomized manner. Specifically, a patient will be given propofol infusion in open-loop mode in the first 5 hours (8:00 a.m. to 1:00 p.m.) and the next 5 hours in closed-loop mode (3:00 p.m. to 8:00 p.m.) with a wash-out period of 2 hours. The order will be randomly determined for each patient. This design will allow the use of the prototype to be evaluated under highly controlled conditions by a trained operator dedicated exclusively to this function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Indication of deep sedation for more than 48 hours

Exclusion Criteria:

• Dementia
• Cranial surgery
• Hypoxic-ischemic encephalopathy
• Chronic liver damage Child C
• History of substance and drug abuse that can alter EEG recordings or the metabolization of drugs (antipsychotics, cocaine, benzodiazepines, opioids)
• Pregnant women
• allergic to propofol
• EEG sensor of the BIS® Covidien cannot be installed

Related Conditions & MeSH terms

• Deep Sedation

Intervention

Device:
• Minimum viable prototype
Deep sedation in critical ill patients using minimum viable prototype
• Usual care
Deep sedation without minimum viable prototype

Locations

Country	Name	City	State
Chile	Hospital Base San José Osorno	Osorno	Los Lagos
Chile	Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile	Santiago	RM
Chile	Hospital Clinico de la Universidad de Chile	Santiago	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infusion rate of propofol	mg/kg/h	Fifth hour
Secondary	Sedation level	Scale SAS (Sedation-Agitation Scale, Score 1-7) (1-2 deeply sedated, 3-4 sedated or calm, 5-6 agitated, and 7 dangerously agitated)	Fifth hour
Secondary	Total dose of propofol	mg	Five hours
Secondary	BIS level	BIS index (bispectral index, values from 0-100, 0 is the minimum, which indicates isoelectric electroencephalographic activity and 100 is the maximun, which indicates awake electroencephalographic activity)	Five hours
Secondary	Suppression rate	Percentage	Five hours
Secondary	Norepinephrine infusion rate	mcg/kg/min	fifth hour