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

• Sponsor: Universitair Ziekenhuis Brussel (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05587803
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12.7
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
RASS-score; Deep Sedation; Post-cardiac Surgery	Device: Neurowave and Sedline indices in view	N/A

Detailed Description

Adequate sedation level is important for patient comfort and safety. As under- and oversedation are common several devices are used that measure the Depth of Anesthesia (DoA). Each device uses its proprietary algorithm to calculate a depth of anesthesia index and each index has its own optimal range. The optimal range for the NeuroSense monitor (NeuroWave Systems inc., Cleveland, OH, USA) is between 40 and 60, while the optimal range for the SEDline monitor (Masimo Corporation; Irvine, CA, USA) is between 25 and 50. When the device indicates a value within these limits, the patient is optimally anesthetized for a surgical procedure. In this study, 30 patients will be monitored simultaneously by both the Neurowave and SedLine devices. The study will determine which device is the most accurate and therefore the most ideal for use in the ICU.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison of NeuroSense/NeuroWave and Sedline/Masimo Indices for Measuring Depth of Sedation in the Intensive Care Unit.
• Actual Study Start Date: May 9, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group 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; 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

Outcome Measures

Primary Outcome Measures

1. Comparison of the depth of sedation indices per assigned RASS score using the prediction probability [33 minutes]

   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 means that an unresponsive patient to any stimuli. 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 with the highest predictive probability correlates best with the clinic and will likely be the best device to use. The predictive probability is calculated using the Jack-Knife method.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Sedated patients admitted in ICU of the University Hospital of Brussels

• Patients who are monitored with the SEDline/Masimo monitor

• Patients sedated with propofol 0,5-4,0 mg/kg/h

• Patients who receive Remifentanil at a maximum concentration of 0,2 μg/kg/min

• Age > 18 years old

Exclusion Criteria:

• Patients with facial trauma

• Pregnant patients

• Patients who received muscle relaxants

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UZ Brussel	Brussels		Belgium	1090

Sponsors and Collaborators

• Universitair Ziekenhuis Brussel

Investigators

• Principal Investigator: Jan Poelaert, MD,PhD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT05587803
• Other Study ID Numbers: 22056PSIWAV
• First Posted: Oct 20, 2022
• Last Update Posted: Oct 20, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Study Results

No Results Posted as of Oct 20, 2022