The Clinical Practice of Palliative Sedation

Study Overview
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Brief Summary
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Palliative Sedation (PS) is defined as the intentional lowering of consciousness of a patient in the last phase of life, to relieve patients suffering from refractory symptoms. For those symptoms all possible effective treatments, within an acceptable timeframe, are exhausted. Several studies have been performed about palliative sedation, mostly focusing on continuous deep sedation, with the use of various measurements to monitor its effect. Efficacy of continuous palliative sedation has been monitored by agitation/distress levels, symptom control, levels of sedation/awareness, comfort, safety and family/caregivers satisfaction. Differences between studies occur, for instance in definition, application and monitoring. Consequently reported outcomes and associated treatment goals differ between studies which makes it difficult to compare the results. Within this international multicenter observational study, the investigators aim to evaluate the effects of palliative sedation on patient's comfort levels. Participants with different forms and intensity of palliative sedation (intermittent and continuous, from light to deep) are included in a prospective design as part of an international study. Objectives: To evaluate the effect of palliative sedation on participants' comfort and other symptoms in different international hospices, palliative care units and hospital ward settings. To assess the clinical practice of palliative sedation in different international care settings and the accompanying costs and consequences. Study design: Prospective observational multicentre study in hospices, palliative care units and hospital ward settings in five European countries (Belgium, Germany, Italy, Spain, The Netherlands).

Official Title
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Palliative Sedation Across European Settings: a Prospective Observational Multicentre Study

Conditions
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Palliative Sedation

Participation Criteria
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Eligibility Criteria
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Phase 1: Participants are eligible for participation in this study when they meet all the following criteria: Adults; with advanced cancer; and a limited life expectancy (1- 2 months); according the health care team, intractable distress caused by one or more refractory symptoms can be expected or is present during the hospitalization. Participants can enter Phase 2 of this study when fulfilling the following preconditions: inclusion criteria for phase 1 are met and informed consent is given by the participant; participant is suffering from intractable distress caused by one or more refractory symptoms according the health care team and/or participant and relatives; sedative medication is started with the aim to relieve burden of otherwise intractable suffering (palliative sedation) Exclusion Criteria: a potential participant is unable to give informed consent; a potential participant is unable to speak and read in the native language of the participating country.

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of discomfort | Change in discomfort levels of participants receiving a form of palliative sedation (PS) will be measured by the Discomfort Scale-Dementia of Alzheimer Type (DS-DAT). The tool covers nine categories: noisy breathing, negative vocalizations, content facial expression, sad facial expression, frightened facial expression, frown, relaxed body language, tense body language, and fidgeting. Items are scored by indicating behaviors that are present/absent with a resulting range of scores from 0 to 27. Higher scores represent higher amount of discomfort. | T0: Baseline before start PS (max. 8 hours before); T1: First measurement after start PS, within 6 hours after start PS; T2-T..: Measurements are continued twice a day during PS until the date of death, on average less than 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of agitation and sedation | Change in levels of agitation and sedation of participants receiving a form of palliative sedation will be measured by the Richmond Agitation Sedation Scale-modified version for Palliative Care (RASS-PAL). This scale is a modified version of the RASS. The RASS-PAL is a 10-point scale ranging from -5 to +4. Levels -1 to -5 denote 5 levels of sedation, starting with awakens to voice and ending with unarousable. Levels +1 to +4 describe increasing levels of agitation. The lowest level of agitation starts with apprehension and anxiety, and peaks at combative and violent. RASS-PAL level 0 is alert and calm. | T0: Baseline before start PS (max. 8 hours before); T1: First measurement after start PS, within 6 hours after start PS; T2-T..: Measurements are continued twice a day during PS until the date of death, on average less than 1 week |