The Clinical Practice of Palliative Sedation

Completed

• Conditions: Palliative Sedation

• Registration Number: NCT04719702
• Lead Sponsor: Radboud University Medical Center

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Study Start: 2021-04-20
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2024-06
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Levels 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	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.

Secondary Outcome Measures

Name	Time	Method
Levels of agitation and sedation	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	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."

Trial Locations

Locations (8)

Katholieke Universiteit Leuven; 🇧🇪 Leuven, Belgium

Radboud University Medical Centre; 🇳🇱 Nijmegen, Netherlands

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

La Maddalena Spa; 🇮🇹 Palermo, Italy

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Spain

Rijnstate Ziekenhuis; 🇳🇱 Arnhem, Netherlands

Hospice Bethlehem - Kalorama; 🇳🇱 Nijmegen, Netherlands

Hospice de Hazelaar, Liemerije; 🇳🇱 Zevenaar, Netherlands