Nociception and BIS Level Monitoring in COVID-19 Patients in the Intensive Care Unit

Completed

• Conditions: Nociceptive Pain
• Interventions: Device: Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel; Device: Bispectral index (BIS); Other: Questionnaire perception of the nurse on pain patient

• Registration Number: NCT05579106
• Lead Sponsor: Leiden University Medical Center

Brief Summary

Pain (nociception), stress and discomfort are difficult to detect in sedated and intubated patients during mechanical ventilation. In order to improve this several nociception level monitors (NOL) were developed that objectively track nociception in sedated or anesthetized patients. Earlier studies showed that for sedated and intubated patients in the operating room, using such monitors is beneficial in reducing stress hormones and post operative pain scores. In this study the investigators aim to observe whether the NOL could be equally beneficial in managing nociception in sedated and intubated ICU patients.

Detailed Description

To date it remains challenging to adequately titrate analgesic medication in sedated and anesthetized patients. Recently, nociception monitoring was introduced to guide analgesic treatment in sedated and anesthetized surgical patients. One such monitor is the Nociception Level (NOL; Medasense Biometrics Ltd., Israel). The NOL combines various measurements such as, skin conductance, heart rate, heart rate variability and photoplethysmograph amplitude, and translates these inputs into a single index ranging from 0 (no nociception) to 100 (maximal nociception). Earlier studies have shown that during surgery, the NOL-guided opioid treatment resulted in improved hemodynamics and reduced postoperative pain.

In the COVID-19 pandemic, patients admitted in the Intensive Care Unit (ICU), needed excessive amounts of sedatives, analgesics and muscle relaxants during mechanical ventilation. To determine its value in the ICU, the investigators measured NOL values in COVID and non-COVID ICU patients in an earlier study. The aim of the investigators was to verify the assumption that COVID-19 patients were overdosed on opioids. Since the investigators indeed did observe lower NOL values in COVID-19 patients than in non-COVID patients in an earlier study, the investigators expanded the study to determine whether sedatives were equally overdosed, by also measuring the bispectral index (BIS). With this extra information the investigators also hope to determine whether it is feasible to use the NOL in the ICU.

Study Timeline

• Study First Submitted: 2022-10-12
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-13
• Study Start: 2022-11-08
• Primary Completion: 2022-12-08
• Study Completion: 2022-12-08
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• aged 18 years or older
• mechanical ventilation for any reason
• deemed suitable by the investigators

Exclusion Criteria

• aged 17 years or younger
• severe peripheral edema
• veno-arterial (VA) and veno-venous (VV) exctracorporeal membrane oxygenation (ECMO)
• heart rate below 35
• abdominal position
• not deemed suitable by the investigators

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
non-COVID-19 patients	Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel	Mechanically ventilated and sedated adult patients not infected with COVID-19 infection. The nociception of this patient will be monitored by the nociception level monitor for 8 hours.
Covid-19 patients	Bispectral index (BIS)	Mechanically ventilated and sedated adult patients with proven COVID-19 infection by PCR of nose- or airway sample. The nociception of this patient will be monitored by the nociception level monitor for 8 hours.
non-COVID-19 patients	Questionnaire perception of the nurse on pain patient	Mechanically ventilated and sedated adult patients not infected with COVID-19 infection. The nociception of this patient will be monitored by the nociception level monitor for 8 hours.
Covid-19 patients	Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel	Mechanically ventilated and sedated adult patients with proven COVID-19 infection by PCR of nose- or airway sample. The nociception of this patient will be monitored by the nociception level monitor for 8 hours.
Covid-19 patients	Questionnaire perception of the nurse on pain patient	Mechanically ventilated and sedated adult patients with proven COVID-19 infection by PCR of nose- or airway sample. The nociception of this patient will be monitored by the nociception level monitor for 8 hours.
non-COVID-19 patients	Bispectral index (BIS)	Mechanically ventilated and sedated adult patients not infected with COVID-19 infection. The nociception of this patient will be monitored by the nociception level monitor for 8 hours.

Primary Outcome Measures

Name	Time	Method
BIS and NOL values over time	8 hours	The observation of the BIS and NOL values over time

Secondary Outcome Measures

Name	Time	Method
Feasibility of using the NOL in the ICU	8 hours	Is it possible to use the NOL on ICU patients and does it monitor correctly
Propofol and opioid dosage	8 hours	Propofol and opioid dosage will be monitored during 8 hours

Trial Locations

Locations (1)

Leiden University Medical Centre; 🇳🇱 Leiden, Zuid-holland, Netherlands