Comparison of 2 Depth of Sedation Indices in the Intensive Care Unit

NCT05587803 | Completed FDA Device

• 1 other identifier: 22056PSIWAV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In the intensive care unit of the Free University hospital of Brussels, sedated patients are standardly monitored with the Masimo SEDline device to see how deeply a patient is asleep. During this study we want to attach 1 extra device to 30 sedated patients, lying in the intensive care unit. This device, called the NeuroSENSE brain monitor from Neurowave systems, uses a different scale to indicate the ideal depth of sedation. In total, both devices will be hung on a patient for 2 times 35 minutes. At minute 33, a RASS score will be determined in each patient. This score will be determined by talking to the patient or administering a pain stimulus. Based on the reaction of the patient an estimation can be made how deeply a patient is sleeping. Our goal is to find out which device correlates best with the effective clinical state of the patient.

Conditions

RASS-score; Deep Sedation; Post-cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• Comparison of the depth of sedation indices per assigned RASS score using the prediction probability

  The main objective of the study is to compare the DoA indices of the NeuroSense/NeuroWave monitor and the SEDline/Masimo monitor in sedated patients in ICU. Both values are then correlated with the patient's clinical sedation level by assigning a RASS score to the patient each time. The RASS score stands for Richmond Agitation Sedation Scale and ranges from -5 to +4. A score of -5 stands for a patient who is unresponsive to any stimuli whereas a score of +4 means a highly combative patient. To determine which device correlates best with the clinic, predictive probability will be used. The prediction probability is a value between 0 and 1. A score of 1 corresponds to a correct classification of the DoA in each case. A value of 0 corresponds to a discordance between the clinic and the index value. The device whose predictive probability is closest to 1 correlates best with the clinic and will likely be the best device to use.

  33 minutes

Study Arms (1)

study group

EXPERIMENTAL

This arm consists of all the patients that fulfill the inclusion and exclusion-criteria and are therefore suitable for the study. The Neurowave brain monitor is attached on the patients forehead and the study starts. At that moment the included patients are monitored by the Masimo/Sedline en the Neurosense/Neurowave monitor.

Device: Neurowave and Sedline indices in view

Interventions

Neurowave and Sedline indices in view DEVICE

3 additional electrodes are attached on the patients forehead. After electrode placement, the indices of both the SEDLINE device and the NEUROWAVE device are noted every 5 seconds for 1 minute

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sedated patients hospitalized in ICU of the University Hospital of Brussels
• Patients who are monitored with the SEDline/Masimo monitor
• Patients who receive Remifentanil at a maximum concentration of 0,2 μg/kg/min and propofol with a concentration between 0,5-4,0 mg/kg/h
• Age above 18 years

You may not qualify if:

• Patients with facial trauma
• Pregnant patients
• Patients who received muscle re-laxants
• Patients in prone position
• Lack of informed consent from the family
• Patients who are hemodynamically unstable
• Patients with neurotrauma or every other neurologic disorder
• Patients post neurosurgery

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

Study Officials

• Jan Poelaert, MD,PhD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 20, 2022
• Study Start: May 9, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 9, 2024

Record last verified: 2023-05

Locations

BE (1)