Measuring Comfort During Palliative Sedation

Study Overview
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Brief Summary
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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

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

Conditions
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Palliative Sedation

Intervention / Treatment
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* Device: NeuroSense monitoring and ANI monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients may be included if they are considered by their treating physician as: in their last week of life in conditions that might, when not treated, cause high levels of distress sedated unable to communicate Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Device monitoring<br>NeuroSense monitoring and ANI monitoring | Device: NeuroSense monitoring and ANI monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. |