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Clinical Trial 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).


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT04719702
Study type Observational
Source Radboud University
Contact Maaike van der Lee-Rijpstra, MSc
Phone +31(0)263651551
Email maaike.vanderlee-rijpstra@radboudumc.nl
Status Recruiting
Phase
Start date April 20, 2021
Completion date March 2023

See also
  Status Clinical Trial Phase
Completed NCT03273244 - Measuring Comfort During Palliative Sedation