Palliative SedationCOMPASNCT03273244
Measuring Comfort During Palliative Sedation
An observational study of Palliative Sedation, run by Vrije Universiteit Brussel at 2 sites in Belgium.
Trial summary
Background. In case of untreatable suffering at the end of life, palliative sedation may be chosen to assure comfort by reducing the patient's level of consciousness. An important question here is whether such sedated patients are certainly completely free of pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Sedation
- What is being tested?
- NeuroSense monitoring and ANI monitoring
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 2 sitesBelgium
- Study dates
- 12 May 2017to 30 Sep 2019
- 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: All patients older than 18 years where palliative sedation is expected to be initiated, regardless of underlying diseases.
Who may be able to join
- Patients may be included if they are considered by their treating physician as:
- in their last week of life
- in conditions that might, when not treated, cause high levels of distress
- sedated
- unable to communicate
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital
Brussels, 1090
Algemeen Ziekenhuis Sint-Blasius
Dendermonde, Oost-Vlaanderen, 9200
About this study
Official title: Towards a Better Understanding of What Palliative Sedated Patients Experience: Linking Numbers to Experiences
Background. In case of untreatable suffering at the end of life, palliative sedation may be chosen to assure comfort by reducing the patient's level of consciousness. An important question here is whether such sedated patients are certainly completely free of pain. Because these patients cannot communicate anymore, caregivers have to rely on observation to assess the patient's comfort. Recently however, more sophisticated techniques from the neurosciences (fMRI, EEG) have shown that sometimes consciousness and pain is undetectable with these traditional behavioral methods.
Therefore there is an urgent need for a more reliable way of assessment by combining existing observational scales, subjective assessments of caregivers and family and neuroimaging techniques.
Read more
Aim. The aim of this study is to better understand how unconscious palliative sedated patients experience the last days of their life and to find out if they are really free of pain.
Methods In this study the investigators will observe 40 patients starting with initiation of palliative sedation until death.
Assessment of comfort based on behavioural observations will be related with the results from a NeuroSense monitor, an EEG-based brain monitor used for evaluation of the adequacy of anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index (ANI) monitor, which informs about the comfort or discomfort condition of the organism, based on the parasympathetic tone (including calculation of ANI). Additionally, the researchers will investigate whether changes of these measures can be linked to changes in the patients' experience as observed by caregivers and relatives, especially in the last moments of life. An innovative and challenging aspect of this study is its qualitative approach, implying all the different types of data will be used to link "objective" and "subjective" data to achieve a holistic understanding of the study topics.
The following data will be collected:
- assessment of pain/comfort by the patients themselves before loss of consciousness due to deep continuous sedation (if possible) by scoring a Visual Analogue Scale (VAS)
- brain function monitoring (NeuroSense monitor)
- monitoring of parasympathetic tone (ANI monitor)
- assessment by caregivers on 3 VAS scales (different scales or 3 different caregivers?)
- relatives' perception of the quality of the dying process on 3 VAS scales (idem)
- assessment by 2 trained investigators using observational scales
- observation: video and audio registration
- Conditions
- Palliative Sedation
- Being tested
- NeuroSense monitoring and ANI monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroSense monitoring and ANI monitoringDevice
From the start of palliative sedation, monitoring of EEG with NeuroSense device (WAVcns: Wavelet Anesthetic Value of the Central Nervous System) and ANI-monitoring (Analgesia Nociception Index) will be initiated.
| Study group | Role | What they receive |
|---|---|---|
| Device monitoring | NeuroSense monitoring and ANI monitoring Receives: Device: NeuroSense monitoring and ANI monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of awareness
Level of awareness as measured by a NeuroSense monitor and expressed as the WAVcns index (Wavelet-based Anesthetic Value for Central Nervous System). The WAVcns is based on cortical EEG.
Measured: From date of enrollment until the date of death, on average less than 1 week.
Level of pain and discomfort
Level of pain and discomfort as measured by an ANI-monitor and expressed by the analgesia nociception index (ANI). The ANI is based on HRV (heart rate variability).
Measured: From date of enrollment until the date of death, on average less than 1 week.
Secondary outcomes (6)
Pain
Visual analog score assessment by nurse
Measured: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
Awareness
Visual analog score assessment by nurse
Measured: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
Communication
Visual analog score assessment by nurse
Measured: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
Pain
Visual analog score assessment by family member
Measured: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
Awareness
Visual analog score assessment by family member
Measured: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
Communication
Visual analog score assessment by family member
Measured: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start12 May 2017
- Primary completion30 Jun 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Palliative SedationStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefaan Six, Vrije Universiteit Brussel
- Investigators
- Reginald Deschepper, PhD, Study chair, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03273244
- Sponsor's protocol ID
- FWOAL768
- Acronym
- COMPAS
- Status last verified
- Oct 2019
- First submitted
- 28 Aug 2017
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Six S, Laureys S, Poelaert J, Mairesse O, Theuns P, Bilsen J, Deschepper R. Neurophysiological Assessments During Continuous Sedation Until Death Put Validity of Observational Assessments Into Question: A Prospective Observational Study. Pain Ther. 2021 Jun;10(1):377-390. doi: 10.1007/s40122-020-00214-z. Epub 2020 Nov 5.
PubMed 33151515Six S, Laureys S, Poelaert J, Bilsen J, Theuns P, Deschepper R. Comfort in palliative sedation (Compas): a transdisciplinary mixed method study protocol for linking objective assessments to subjective experiences. BMC Palliat Care. 2018 Apr 18;17(1):62. doi: 10.1186/s12904-018-0316-2.
PubMed 29669562
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Towards a Better Understanding of What Palliative Sedated Patients Experience: Linking Numbers to Experiences
- ClinicalTrials.gov ID
- NCT03273244
- Acronym / sponsor ID
- COMPAS / FWOAL768
- Conditions
- Palliative Sedation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Sep 2017 (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.
Background. In case of untreatable suffering at the end of life, palliative sedation may be chosen to assure comfort by reducing the patient's level of consciousness. An important question here is whether such sedated patients are certainly completely free of pain. Because these patients cannot communicate anymore, caregivers have to rely on observation to assess the patient's comfort. Recently however, more sophisticated techniques from the neurosciences (fMRI, EEG) have shown that sometimes consciousness and pain is undetectable with these traditional behavioral methods.
Therefore there is an urgent need for a more reliable way of assessment by combining existing observational scales, subjective assessments of caregivers and family and neuroimaging techniques.
Aim. The aim of this study is to better understand how unconscious palliative sedated patients experience the last days of their life and to find out if they are really free of pain.
Methods In this study the investigators will observe 40 patients starting with initiation of palliative sedation until death.
Assessment of comfort based on behavioural observations will be related with the results from a NeuroSense monitor, an EEG-based brain monitor used for evaluation of the adequacy of anesthesia and sedation in the operating room and an ECG-based Analgesia Nociception Index (ANI) monitor, which informs about the comfort or discomfort condition of the organism, based on the parasympathetic tone (including calculation of ANI). Additionally, the researchers will investigate whether changes of these measures can be linked to changes in the patients' experience as observed by caregivers and relatives, especially in the last moments of life. An innovative and challenging aspect of this study is its qualitative approach, implying all the different types of data will be used to link "objective" and "subjective" data to achieve a holistic understanding of the study topics.
The following data will be collected:
- assessment of pain/comfort by the patients themselves before loss of consciousness due to deep continuous sedation (if possible) by scoring a Visual Analogue Scale (VAS)
- brain function monitoring (NeuroSense monitor)
- monitoring of parasympathetic tone (ANI monitor)
- assessment by caregivers on 3 VAS scales (different scales or 3 different caregivers?)
- relatives' perception of the quality of the dying process on 3 VAS scales (idem)
- assessment by 2 trained investigators using observational scales
- observation: video and audio registration
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device monitoring | – | Device: NeuroSense monitoring and ANI monitoringNeuroSense monitoring and ANI monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients older than 18 years where palliative sedation is expected to be initiated, regardless of underlying diseases.
Key inclusion criteria (5 listed)
- in their last week of life
- in conditions that might, when not treated, cause high levels of distress
- sedated
- unable to communicate
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| NeuroSense monitoring and ANI monitoringFrom the start of palliative sedation, monitoring of EEG with NeuroSense device (WAVcns: Wavelet Anesthetic Value of the Central Nervous System) and ANI-monitoring (Analgesia Nociception Index) will be initiated. | Device | Device monitoring |
Primary outcome
Level of awareness
Time frame: From date of enrollment until the date of death, on average less than 1 week.
Level of awareness as measured by a NeuroSense monitor and expressed as the WAVcns index (Wavelet-based Anesthetic Value for Central Nervous System). The WAVcns is based on cortical EEG.
Level of pain and discomfort
Time frame: From date of enrollment until the date of death, on average less than 1 week.
Level of pain and discomfort as measured by an ANI-monitor and expressed by the analgesia nociception index (ANI). The ANI is based on HRV (heart rate variability).
6 secondary outcomes
Pain
Time frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
Awareness
Time frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
Communication
Time frame: From date of enrollment until the date of death (on average less than 1 week), during routine care, at least twice a day.
Pain
Time frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
Awareness
Time frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
Communication
Time frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
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 18 Oct 2019.
- Derived from this study: PubMed 33151515Six S, Laureys S, Poelaert J, Mairesse O, Theuns P, Bilsen J, Deschepper R. Neurophysiological Assessments During Continuous Sedation Until Death Put Validity of Observational Assessments Into Question: A Prospective Observational Study. Pain Ther. 2021 Jun;10(1):377-390. doi: 10.1007/s40122-020-00214-z. Epub 2020 Nov 5.
- Derived from this study: PubMed 29669562Six S, Laureys S, Poelaert J, Bilsen J, Theuns P, Deschepper R. Comfort in palliative sedation (Compas): a transdisciplinary mixed method study protocol for linking objective assessments to subjective experiences. BMC Palliat Care. 2018 Apr 18;17(1):62. doi: 10.1186/s12904-018-0316-2.
Related trials for Palliative Sedation
Not yet recruiting
End-of-life Care in Mechanically Ventilated Patients: Impact of a Comprehensive Palliative Care Protocol in the Intensive Care Setting
Palliative Care, Withdrawal of Life Support
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.
Reginald Deschepper, PhD study chair
Vrije Universiteit Brussel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Sedation, run by Vrije Universiteit Brussel at 2 sites in Belgium.
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 5 inclusion and 1 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
Level of awareness (time frame: From date of enrollment until the date of death, on average less than 1 week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03273244, which also lists 2 linked publications.
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 18 Oct 2019.