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

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Nociceptive Pain

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

Study type: Observational

Funder types: Other

Identifiers

NCT05579106

CoCo 2021-017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

Covid-19 patients

Description:

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.

Treatment:

Other: Questionnaire perception of the nurse on pain patient

Device: Bispectral index (BIS)

Device: Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel

non-COVID-19 patients

Description:

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.

Treatment:

Other: Questionnaire perception of the nurse on pain patient

Device: Bispectral index (BIS)

Device: Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel