• To evaluate the effect of palliative sedation on patients comfort and other symptoms in different international hospices, palliative care units and hospital ward settings.• To assess the clinical practice of palliative sedation in different…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Alle patienten met een primaire diagnose van kanker
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in discomfort levels of patients receiving palliative sedation, measured
by the health care professionals using the DS-DAT, a Discomfort Score for
patients with Dementia Alzheimer Type. Measured before and twice a day during
the whole procedure of palliative sedation until death. This measure has been
succesfully applied in sedated patients in previous studies, for example from
Radboudumc.
Secondary outcome
Depth of sedation and levels of agitation are measured with the Richmond
Agitation Sedation Scale, modified version for palliative care (RASS-PALL).
Background summary
Palliative sedation 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.
Study objective
• To evaluate the effect of palliative sedation on patients comfort and other
symptoms in different international hospices, palliative care units and
hospital ward settings.
• 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).
Study burden and risks
Since our study will be observational, following regular practice, the expected
amount of extra burden due to study participation will be low.
Geert Grootplein Zuid 10
Nijmegen 6500 HB
NL
Geert Grootplein Zuid 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
* Age 18 years or above;
* Primary diagnosis at admission is advanced cancer;
* Life expectancy of the patient is limited (clinical prognosis estimation 1-2
months);
* Intractable distress caused by one or more refractory symptoms during the
hospitalization can be expected or is present, according the health care team;
* Able to give informed consent, or there is a possibility of proxy informed
consent.
Exclusion criteria
* When a potential participant is unable to give informed consent and there is
no possibility of proxy informed consent, he/she is not eligible for
participation in this study.
* When a potential participant and/or the relative is unable to speak and read
in the native language of the participating country, he/she is not eligible for
participation in this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT04719702 |
| CCMO | NL72725.091.20 |