Nociceptive PainNEMONCT05579106
Nociception and BIS Level Monitoring in COVID-19 Patients in the Intensive Care Unit
An observational study of Nociceptive Pain, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nociceptive Pain
- What is being tested?
- Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel, Bispectral index (BIS) and Questionnaire perception of the nurse on pain patient
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Nov 2022to 8 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- aged 18 years or older
- mechanical ventilation for any reason
- deemed suitable by the investigators
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Centre
Leiden, South Holland, 2333ZA
About this study
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.
Read the 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.
- Conditions
- Nociceptive Pain
- Being tested
- Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel, Bispectral index (BIS), Questionnaire perception of the nurse on pain patient
- Medical subject headings
- Nociceptive Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., IsraelDevice
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 patientOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel; Device: Bispectral index (BIS); Other: Questionnaire perception of the nurse on pain patient |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS and NOL values over time
The observation of the BIS and NOL values over time
Measured: 8 hours
Secondary outcomes (2)
Propofol and opioid dosage
Propofol and opioid dosage will be monitored during 8 hours
Measured: 8 hours
Feasibility of using the NOL in the ICU
Is it possible to use the NOL on ICU patients and does it monitor correctly
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start8 Nov 2022
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nociceptive PainStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Dahan, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579106
- Sponsor's protocol ID
- CoCo 2021-017
- Acronym
- NEMO
- Status last verified
- Mar 2023
- First submitted
- 12 Oct 2022
- Last updated
- 8 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nociception and BIS Level Monitoring in COVID-19 Patients in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05579106
- Acronym / sponsor ID
- NEMO / CoCo 2021-017
- Conditions
- Nociceptive Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Covid-19 patients | – | Device: Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel, Device: Bispectral index (BIS), Other: Questionnaire perception of the nurse on pain patientMechanically 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. |
| non-COVID-19 patients | – | Device: Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., Israel, Device: Bispectral index (BIS), Other: Questionnaire perception of the nurse on pain patientMechanically 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- aged 18 years or older
- mechanical ventilation for any reason
- deemed suitable by the investigators
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nociception Level Monitor (NOL) by Medasense Biometrics Ltd., IsraelThe 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 | Covid-19 patients, non-COVID-19 patients |
| 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. | Device | Covid-19 patients, non-COVID-19 patients |
| Questionnaire perception of the nurse on pain patientThe 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. | Other | Covid-19 patients, non-COVID-19 patients |
Primary outcome
BIS and NOL values over time
Time frame: 8 hours
The observation of the BIS and NOL values over time
2 secondary outcomes
Propofol and opioid dosage
Time frame: 8 hours
Feasibility of using the NOL in the ICU
Time frame: 8 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nociceptive Pain, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS and NOL values over time (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2023.