Commonly the assessment and management of symptoms in palliative care patients depends on the experience of nurses en doctors. So far objective methods are not or hardly used to determine the presence and seriousness of symptoms. The main goal of…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
palliatieve zorg
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary research question:
Can comfort be monitored in palliative care patients in a nursing home by
measuring sedation, pain and delirium?
Secondary outcome
Secundary research question:
Is the Bispectral index (BIS) monitor valid to measure depth of sedation in
palliative care patients in a nursing home and associated with the given
medication?
Is a change in BIS score correlated to a change in medication given to
influence the depth of sedation?
Background summary
Near the end of life various symptoms can be seen. Pain and delirium are two
symptoms that frequently accompany the nearing death.
The assessment of pain and delirium in nursing home patients and palliative
care patients is often poor. Therefore, several tools to evaluate symptoms have
been developed. For pain the Rotterdam Elderly Pain Observation Scale (REPOS)
is a promising observation scale. This scale measures pain in nursing home
patients with cognitive impairments, communication difficulties, or both. Among
these patients can be patients in terminal stages of illness. For the detection
of delirium, the Delirium Observation Screening (DOS) scale has been developed.
Palliative sedation is the intentional induction of sleep in patients with a
very short life expectancy who suffer intractable distress. The aim of
palliative sedation is to provide comfort. At the end of life palliative
sedatie can be an option, when standard therapy to relieve symptoms is
inadequate and symptoms seems to become untreatable. It is estimate that in the
Netherlands palliative sedation is used by doctors in 10% of all mortality
cases per year. The indications most mentioned in palliative sedation are pain,
dyspnea and delirium/terminal restlessness. The efficacy and safety of
palliative sedation have been hardly described. Besides, so far it is unusual
to objectify palliative sedation.
The depth of sedation can be measured with observation scales, like the Ramsay
scale, or with neurofysiological monitors. The most and best studied monitor is
the Bispectral Index (BIS) monitor. In palliative care the use of the BIS
monitor has been described still very limited.
Commonly the assessment and management of symptoms in palliative care patients
depends on the experience of nurses en doctors. So far objective methods are
not or hardly used to determine the presence and seriousness of symptoms.
Study objective
Commonly the assessment and management of symptoms in palliative care patients
depends on the experience of nurses en doctors. So far objective methods are
not or hardly used to determine the presence and seriousness of symptoms.
The main goal of the study is to validate the BIS monitor during palliative
sedation. Another aim is to monitor the degree of comfort in (sedated)
palliative care patients in a nursing home. For this the BIS monitor and Ramsay
score are used to measure the depth of sedation, the Numeric Rating Scale (NRS)
and REPOS are used to qualify pain, the DOS scale is used to determine
delirium, a comfort scale asked at patients and next of kin is used as general
measurement for comfort and a comfort scale asked at caregivers is used as en
expert opinion.
Study design
Prospective observational pilot study
Parameters:
- Data of medical file: birth date/(age), gender, data of admission in nursing
home, diagnoses/morbidity, all medication (fixed and if indicated) with doses
and route of administration, every change in medication with date and time,
indication for sedation, duration from sedation till pass away.
- Pain: NRS/REPOS score. Done at fixed times before and during sedation. In
patients whom can express themselves verbally, the NRS is used to measure pain.
The REPOS will be used at the same time with the NRS, when the NRS seems to be
unreliable. The REPOS is used in verbally impaired patients. Daily caregivers
give a NRS for the patients pain.
- Delirium: DOS score. Three times in 24hours at regular moments of care.
- Comfort: Numeric Rating Scale. Daily patient, next of kin and caregiver give
a score from 0 (totally no comfort) to 10 (optimal comfort).
- Fysical parameters: Daily measuring respiration rate, respiration regularity
(normal/Cheyne Stokes) and cardiac rate.
- Sedation: BIS scores and Ramsay score. Taking a score before sedation: at
daytime during 1hour and at night time during sleep. During sedation continuing
monitoring, with covered monitor. Ramsay score is done at fixed times.
Study burden and risks
This study uses non-invasive measurements for sedation, pain and delirium and
BIS monitoring. The participant will be visited every day during maximal 15
minutes. During such visits assessments will be done and if necessary the BIS
sensor is checked or replaced. The BIS sensor can cause local redness of the
skin.
Zamenhofstraat 4 (prive A.D. Masman)
2312 NV Leiden
Nederland
Zamenhofstraat 4 (prive A.D. Masman)
2312 NV Leiden
Nederland
Listed location countries
Age
Inclusion criteria
Patients in terminal stages of illness at palliative unit in nursing home Laurens, Antonius IJsselmonde, Rotterdam; informed consent
Exclusion criteria
no informed consent;
time too short to take a BIS score before sedation
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 |
---|---|
CCMO | NL22500.078.08 |