NCT04719702

The Clinical Practice of Palliative Sedation

Palliative Sedation Across European Settings: a Prospective Observational Multicentre Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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: 1. To evaluate the effect of palliative sedation on participants' comfort and other symptoms in different international hospices, palliative care units and hospital ward settings. 2. 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).

Conditions

• Palliative Sedation

Timeline

• Start date: 2021-04-20
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2021-01-22
• Last updated: 2024-07-03

Locations

8 sites across 5 countries: Belgium, Germany, Italy, Netherlands, Spain