Electroencephalogram Based Real-Time Sedation Level Prediction

Procedural Sedation Clinical Trial

— EBSPA  

Official title:

Electroencephalogram Based Real-Time Sedation Level Prediction Using Artificial Intelligence

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05757622
• Other study ID #: 16097
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: March 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational pilot study. Patients undergoing elective surgery or Cath lab interventions under general anesthesia or procedural sedation at the department of anesthesiology at the UMCG will be enrolled.

1. Recruitment procedure:

Patients identified as eligible for the study by research/clinical staff will be enrolled after written informed consent. Clinical staff involved in this study will approach the patient for obtaining informed consent prior to the scheduled procedure, according to the UMCG´s daily published OR/Cath lab schedule. Patients enrolled in this study will receive standard clinical care, as defined in the standard operating procedures of the department of Anesthesiology.

2. Monitor and recording set up:

1. A vital sign monitor will continuously record routine physiological data, including ECG, noninvasive and/or invasive blood pressure (blood pressure cuff and/or arterial line), and pulse oximetry.

2. The noninvasive EEG-monitor A disposable sensor will be attached to the forehead of the patient and passive recording of EEG and physiological data will begin prior to induction of anesthesia at the OR or Cath lab.

3. Vital sign monitor and EEG-monitor used for this study are mounted permanently on the anesthesia machine and sedation workstation which is used routinely at the department of Anesthesiology and data obtained are directly streamed to the UMCG patient data record system , and stored monitor for case-based wave analysis.

3. Sedation/Pain assessments:

As per routine clinical practice, the investigators will use Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) scoring system for sedation assessment system for pain assessment. During each assessment MOAA/S scores will be determined prior to induction of anesthesia or sedation, during the procedure, and after the procedure until the patient leaves the operating room/cath lab.

Description:

This is an observational pilot study. Patients undergoing elective surgery or Cath lab interventions under general anesthesia or procedural sedation at the department of anesthesiology at the UMCG will be enrolled.

1. Recruitment procedure:

Patients identified as eligible for the study by research/clinical staff will be enrolled after written informed consent. Clinical staff involved in this study will approach the patient for obtaining informed consent prior to the scheduled procedure, according to the UMCG´s daily published OR/Cath lab schedule. Patients enrolled in this study will receive standard clinical care, as defined in the standard operating procedures of the department of Anesthesiology.

2. Monitor and recording set up:

1. A vital sign monitor will continuously record routine physiological data, including ECG, noninvasive and/or invasive blood pressure (blood pressure cuff and/or arterial line), and pulse oximetry.

2. The noninvasive EEG-monitor A disposable sensor will be attached to the forehead of the patient and passive recording of EEG and physiological data will begin prior to induction of anesthesia at the OR or Cath lab.

3. Vital sign monitor and EEG-monitor used for this study are mounted permanently on the anesthesia machine and sedation workstation which is used routinely at the department of Anesthesiology and data obtained are directly streamed to the UMCG patient data record system , and stored in the monitor for case-based wave analysis.

3. Sedation/Pain assessments:

As per routine clinical practice, the investigators will use Modified Observer's Assessment of Alertness/Sedation Scale (MOAA/S) scoring system for sedation assessment at each level of sedation. During each assessment , MOAA/S scores will be determined prior to induction of anesthesia or sedation, during the procedure, and after the procedure until the patient leaves the operating room/cath lab.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: April 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 18 years, undergoing elective procedures under general anesthesia or procedural sedation

Exclusion Criteria:

• Deemed unsuitable for selection by the research team or service care providers due to any medical, legal, social, or interpersonal issues that would either compromise the study or the routine care of patients.

Related Conditions & MeSH terms

• Procedural Sedation

Intervention

Drug:
• Propofol
Procedural sedation provided with propofol and remifentanil using target controlled infusions
• Remifentanil
Procedural sedation provided with propofol and remifentanil using target controlled infusions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG	EEG recordings during procedural sedation	From 5 minutes prior to start if induction to full awakening
Primary	Vital signs	Changes in Vital signs associated with the level of procedural sedation	From 5 minutes prior to start if induction to full awakening
Primary	MOAAS score	sedation depth scoring using the MOAAS score	From 5 minutes prior to start if induction to full awakening