Measuring Comfort During Palliative Sedation (COMPAS)

October 17, 2019 updated by: Stefaan Six, Vrije Universiteit Brussel

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.

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • University Hospital
    • Oost-Vlaanderen
      • Dendermonde, Oost-Vlaanderen, Belgium, 9200
        • Algemeen Ziekenhuis Sint-Blasius

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients older than 18 years where palliative sedation is expected to be initiated, regardless of underlying diseases.

Description

Inclusion Criteria:

Patients may be included if they are considered by their treating physician as:

  1. in their last week of life
  2. in conditions that might, when not treated, cause high levels of distress
  3. sedated
  4. unable to communicate

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Device monitoring
NeuroSense monitoring and ANI monitoring
Device: NeuroSense monitoring and ANI monitoring
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From date of enrollment until the date of death, on average less than 1 week.
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).
From date of enrollment until the date of death, on average less than 1 week.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Visual analog score assessment by nurse
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.
Visual analog score assessment by nurse
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.
Visual analog score assessment by nurse
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.
Visual analog score assessment by family member
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.
Visual analog score assessment by family member
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.
Visual analog score assessment by family member
From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vrije Universiteit Brussel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 18, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FWOAL768

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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