MedTrace Logo

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

NCT05579106 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-03-08

No results posted yet for this study

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.

Conditions

  • Nociceptive Pain

Interventions

DEVICE

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

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.

DEVICE

Bispectral index (BIS)

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.

OTHER

Questionnaire perception of the nurse on pain patient

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.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-08
Primary Completion
2022-12-08
Completion
2022-12-08

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579106 on ClinicalTrials.gov