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NCT Number: NCT05579106

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

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.

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Key information

Conditions

Nociceptive Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Centre

Leiden, South Holland, 2333ZA, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

The NOL monitor measures various parameters via a sensor in a finger probe that is attached to the patient.

These parameters are:

  • Temperature
  • Galvanic skin response
  • Accelerometer
  • Photoplethysmograph (pulse rate, pulse rate variability, photoplethysmograph amplitude)

All this data is combined in an algorithm which produces a number between 0-100. Between 10-25 indicates adequate analgesia, below 10 too much analgesia, above 25 too little analgesia. No actions are taken based on this measurement.

Bispectral index (BIS)

Device

The BIS processes EEG information to provide a direct measurement of the patient's level of consciousness and insight into the effects of anesthesia on the brain.

Questionnaire perception of the nurse on pain patient

Other

The investigators developed a questionnaire with 7-questions regarding the perception of the responsible nurse on the pain of the patient. When the investigators measured for 8 hours with the BIS and the NOL they will ask the nurse what his or her perception was of the pain of the patient. Eventually the investigators will compare the answers of this questionnaire with the NOL and BIS values that they observed, whether the information corresponds or not.

Primary outcomes

  1. BIS and NOL values over time

    Time frame: 8 hours

    The observation of the BIS and NOL values over time

Secondary outcomes

  1. Propofol and opioid dosage

    Time frame: 8 hours

    Propofol and opioid dosage will be monitored during 8 hours

  2. Feasibility of using the NOL in the ICU

    Time frame: 8 hours

    Is it possible to use the NOL on ICU patients and does it monitor correctly

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Acronym: NEMO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 13, 2022
Registry last updated
Mar 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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