Palliative Sedation Clinical Trial
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.
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
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04719702 -
The Clinical Practice of Palliative Sedation
|