An observational study in Palliative Sedation, sponsored by Vrije Universiteit Brussel. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-18.
Sponsored by Vrije Universiteit Brussel · Observational
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:
All patients older than 18 years where palliative sedation is expected to be initiated, regardless of underlying diseases.
Patients may be included if they are considered by their treating physician as:
Exclusion Criteria:
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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.
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.
Time frame: 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).
Time frame: From date of enrollment until the date of death, on average less than 1 week.
Pain
Visual analog score assessment by nurse
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
Visual analog score assessment by nurse
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
Visual analog score assessment by nurse
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
Visual analog score assessment by family member
Time frame: 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
Time frame: 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
Time frame: From date of enrollment until the date of death (on average less than 1 week), during visit, once a day.
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Vrije Universiteit Brussel