Clinical trial NCT05579106: Nociception and BIS Level Monitoring in COVID-19 Patients in the Intensive Care Unit
Official title: Nociception and BIS Level Monitoring in COVID-19 Patients in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nociceptive Pain
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to the ICU meeting the above mentioned selection criteria can be included in the study. Only half of the included patients will have proven COVID-19 disease by PCR of nose- or airway sample. The Control patients (without COVID-19) will be randomly selected. There will be no matching.

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.

Eligibility criteria: 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

Primary outcomes:
measure: BIS and NOL values over time
timeFrame: 8 hours
Secondary outcomes:
measure: Propofol and opioid dosage
timeFrame: 8 hours
measure: Feasibility of using the NOL in the ICU
timeFrame: 8 hours
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
state: Zuid-holland
Study officials:
References: