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

NCT05579106 | Completed

• 1 other identifier: CoCo 2021-017
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Nociceptive Pain

Outcome Measures

Primary Outcomes (1)

• BIS and NOL values over time

  The observation of the BIS and NOL values over time

  8 hours

Secondary Outcomes (2)

• Propofol and opioid dosage

  8 hours

• Feasibility of using the NOL in the ICU

  8 hours

Study Arms (2)

Covid-19 patients

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.

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

non-COVID-19 patients

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.

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

Interventions

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.

Covid-19 patients; non-COVID-19 patients

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.

Covid-19 patients; non-COVID-19 patients

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.

Covid-19 patients; non-COVID-19 patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Centre

Leiden, South Holland, 2333ZA, Netherlands

Location

MeSH Terms

Conditions

Nociceptive Pain

Interventions

Consciousness Monitors

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Anesthesiology

Study Record Dates

• First Submitted: October 12, 2022
• First Posted: October 13, 2022
• Study Start: November 8, 2022
• Primary Completion: December 8, 2022
• Study Completion: December 8, 2022
• Last Updated: March 8, 2023

Record last verified: 2023-03

Locations

NL (1)