Measuring Comfort During Palliative Sedation

Palliative Sedation Clinical Trial

— COMPAS  

Official title:

Towards a Better Understanding of What Palliative Sedated Patients Experience: Linking Numbers to Experiences

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03273244
• Other study ID #: FWOAL768
• Status: Completed
• Start date: May 12, 2017
• Est. completion date: September 30, 2019

Study information

• Verified date: October 2019
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Palliative Sedation

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital	Brussels
Belgium	Algemeen Ziekenhuis Sint-Blasius	Dendermonde	Oost-Vlaanderen

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of enrollment until the date of death, on average less than 1 week.
Primary	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).	From date of enrollment until the date of death, on average less than 1 week.
Secondary	Pain	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.
Secondary	Awareness	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.
Secondary	Communication	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.
Secondary	Pain	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.
Secondary	Awareness	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.
Secondary	Communication	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.