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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

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)

May 12, 2017

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

August 28, 2017

First Submitted That Met QC Criteria

September 1, 2017

First Posted (Actual)

September 6, 2017

Study Record Updates

Last Update Posted (Actual)

October 18, 2019

Last Update Submitted That Met QC Criteria

October 17, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Other Study ID 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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