Monitoring the clinical practice of palliative sedation (PALSED) in patients with advanced cancer: an international, multicentre, non-experimental prospective observational study protocol

BMC Palliative Care

Study Protocol

Carlos Centeno¹  Kris Vissers²  Evelien Kuip²  Johan Menten³  Michael Van der Elst³  Lukas Radbruch⁴  Jeroen Hasselaar⁵  Maaike Rijpstra⁶  Maria Arantzamendi⁷  Sheila Payne⁸  Nancy Preston⁸  Claudio Adile⁹  Sebastiano Mercadante⁹ 

[1] Departement of Palliative Medicine, Clínica Universidad de Navarra, Pamplona, Spain;Institute for Culture and Society-ATLANTES, Universidad de Navarra, Pamplona, Spain;IdISNA, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain;Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands;Department of Oncology, Laboratory of Experimental Radiotherapy, Katholieke Universiteit Leuven, Leuven, Belgium;Department of Palliative Medicine, Universitaetsklinikum Bonn, Bonn, Germany;Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands;Department of Primary and Community Care, Radboud University Medical Centre, Nijmegen, the Netherlands;Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Center, Nijmegen, The Netherlands;Institute for Culture and Society-ATLANTES, Universidad de Navarra, Pamplona, Spain;IdISNA, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain;International Observatory On End of Life Care, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK;Main Regional Center of Supportive/Palliative Care, La Maddalena Cancer Center, Palermo, Italy;

关键词: Palliative sedation;    Observational study;    End of life care;    Advanced Cancer;    Monitoring;   

DOI  :  10.1186/s12904-022-01125-w

 received in 2022-11-24, accepted in 2022-12-21,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundPalliative sedation involves the intentional lowering of consciousness at the end of life. It can be initiated to relieve a patient’s burden caused by refractory symptoms at the end of life. The impact of palliative sedation needs to be clinically monitored to adjust the proper dose and regimen of sedative medication to ensure that patients are at ease and comfortable at the end of their lives. Although there is consensus among health care professionals and within guidelines that efficacy of palliative sedation needs to be closely monitored, there is no agreement about how, when, and by whom, this monitoring should be performed. The aim of this study is to evaluate the effects of palliative sedation by measuring the discomfort levels and sedation/agitation levels of the patients at regular timepoints. In addition, the clinical trajectories of those patients receiving palliative sedation will be monitored and recorded.MethodsThe study is an international prospective non-experimental observational multicentre study. Patients are recruited from in-patient palliative care settings in Belgium, Germany, Italy, Spain and the Netherlands. Adult patients with advanced cancer are monitored by using proxy observations of discomfort (DS-DAT) and depth of sedation/agitation levels (RASS-PAL) during palliative sedation. After the palliative sedation period, the care for the specific participant case is evaluated by one of the attending health care professionals and one relative via a questionnaire.DiscussionThis study will be the first international prospective multicenter study evaluating the clinical practice of palliative sedation including observations of discomfort levels and levels of sedation. It will provide valuable information about the practice of palliative sedation in European countries in terminally ill cancer patients. Results from this study will facilitate the formulation of recommendations for clinical practice on how to improve monitoring and comfort in patients receiving palliative sedation.Trial registrationThis study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.

【 授权许可】

CC BY   
© The Author(s) 2023

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