TY - JOUR

T1 - Monitoring the clinical practice of palliative sedation (PALSED) in patients with advanced cancer

T2 - an international, multicentre, non-experimental prospective observational study protocol

AU - Rijpstra, Maaike

AU - Vissers, Kris

AU - Centeno, Carlos

AU - Menten, Johan

AU - Radbruch, Lukas

AU - Mercadante, Sebastiano

AU - Van der Elst, Michael

AU - Adile, Claudio

AU - Arantzamendi, Maria

AU - Kuip, Evelien

AU - Payne, Sheila

AU - Preston, Nancy

AU - Hasselaar, Jeroen

PY - 2023/1/28

Y1 - 2023/1/28

N2 - Background: Palliative 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. Methods: The 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. Discussion: This 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 registration: This study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.

AB - Background: Palliative 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. Methods: The 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. Discussion: This 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 registration: This study is registered at Clinicaltrials.gov since January 22, 2021, registration number: NCT04719702.

KW - Study Protocol

KW - Palliative sedation

KW - Observational study

KW - End of life care

KW - Advanced Cancer

KW - Monitoring

U2 - 10.1186/s12904-022-01125-w

DO - 10.1186/s12904-022-01125-w

M3 - Journal article

VL - 22

JO - BMC Palliative Care

JF - BMC Palliative Care

SN - 1472-684X

IS - 1

M1 - 8

ER -