Can administration of scopolaminebutyl from the start of the dying phase prevent death rattle during the dying phase?
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Reutelen in stervensfase, Ademhalingsstelsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of patients who develop death rattle, defined as the appearance
of grade 2 or higher according to the method of Back measured at 2 successive
times/time points with an interval of 4 hours.
The following degrees of rattle are distinguished:
grade 0 = no audible rattle
grade 1 = rattle only audible close to the patient
grade 2 = rattle in a quiet room clearly audible at the foot of the bed
grade 3 = rattle in a quiet room audible at a distance of 10 meters (at the
door of a room)
Secondary outcome
- Time from recognition of the dying phase until death rattle
- Appearance of the adverse events micturition, dry mouth and restlessness by
observations noted in the digital Care plan of the dying (formerly known as
Liverpool Care Pathway)
- Quality of life during the last three days of the life of the patient,
according to the
caregiver, indicated by a numerical value on a scale of 0 to 10 (0 = no
quality; 10 = the best quality that can be imagined)
- Quality of dying of the patient, according to the caregiver, indicated by a
numerical value on a scale of 0 to 10 (0 =no quality; 10 = the best quality
that can be imagined )
- Manner of death, according to the caregiver, indicated with 15 qualitative
terms.
- Moment of death, according to the caregiver, indicated with 15 qualitative
terms.
- Quality of Life in the last three days of the patient according to the
relatives, indicated with a numerical value on a scale of 0 to 10 (0 =no
quality; 10 = the best quality that can be imagined )
- Quality of dying of the patient, indicated by the relatives, indicated with a
numerical value on a scale of 0 to 10 (0 = no quality; 10 = the best quality
that can be imagined )
- The way of dying, according to the relatives, indicated with 15 qualitative
terms.
- Moment of death, according to the relatives, indicated with 15 qualitative
terms.
- Extent of bereavement for relatives according to the Leiden Score (15)
- Experience of participating in a (double-blind, placebo-controlled)
scientific research trial through a questionnaire and interviews with questions
about the perception and the meaning of participating in a trial indicated by a
numerical value on a scale of 1 to 4 (1 = no stress; 4 = extremely stressful)
Background summary
About half of the patients in the dying phase experience death rattle: noisy
breathing caused by the presence of mucus in the upper respiratory tract.
Patients may be afraid of the occurrence of/to experience death rattle by
memories of the dying process/phase of loved ones. If this loved one had
experienced death rattle, it could be interpreted as *choking*. For relatives
of a patient the rattling noise can be unpleasant and disturbing.
They may fear that their loved one suffers from it and will choke. Creating
awareness by informing the patient and relatives and helping drainage of the
mucus by regularly posture changes of the bedridden patient are recommended in
the Dutch guideline. If the rattle is nevertheless perceived as burdensome,
administration of medication (anticholinergics) can be considered. However,
there is no evidence for the effect of this medication on the death rattle.
Because the medication does nothing to the existing mucus, it seems to be more
rational to start with medication before the death rattle exists.
Study objective
Can administration of scopolaminebutyl from the start of the dying phase
prevent death rattle during the dying phase?
Study design
double-blind randomised, placebo-controlled multicenter study
Intervention
Immediately after starting of the dying phase, and the registration of the
first observations, the patient is administered the study drug: scopolamine 1
ml s.c. (= 20 mg) or placebo 1 ml s.c..
This is repeated every 6 hours. The study stops when at 2 consecutive times of
measurement at an interval of 4 hours, death rattle grade 2 or more is found or
when patient had died.
Study burden and risks
It is expected that there will be no serious side effects related to the use of
hyoscine butylbromide during the dying phase. Hyoscine butylbromide is a
well-known drug which is used regularly in the dying phase and with almost no
side effects in practice.
In Anglo-Saxon countries these agents are used standard in case of death rattle
during the dying phase. Early use of the medication may increase the risk of
side effects. Potential side effects are related to the effect of the drug on
the parasympatic system, such as tachycardia, urine retention, dry mouth.
However, these symptoms may also occur as part of the dying process and may
not be related with hyoscine butylbromide. Normal nursing care, such as the
use of a urinary catheter and regular oral care, will be delivered . In the
elderly the risk of cognitive impairment or delirium is increased. The
possible side effects will be marked in the digital version of the Care pathway
for the dying when they appeared during this dying phase. Observations will be
regularly done/performed (at least every 4 hours), registration will be done
every 4 hours.
There is no direct benefit to the patient from/by participating in this study.
This research could contribute to properly care in the dying phase by making
clear whether the prophylactic use of hyoscine butylbromide is effective.
It is not clear whether participating in a placebo-controlled randomized trial
might have impact on the quality of death of the patient and / or on the
well-being of the relatives. This is investigated by questionnaires and
interviews (secondary outcome).
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
1. Admission for care and treatment in one of the participating hospice facilities
2. It is known by the patient and his/her relatives that the admission will be up to death
3. At admission life expectancy is at least 3 days
4. At explanation of the study (shortly after admission to hospice facility) and signing of the informed consent the patient is conscious
5. Presence of a signed informed consent
Exclusion criteria
1. There are signs of a respiratory infection (upper or lower respiratory tract)
2. The patient has a tracheostomy or tracheocanula
3. The patient uses an anticholinergic or octreotide
4. At the start/At recognition of the dying phase death rattle is present at grade 1 or more, according to Back
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002287-14-NL |
| CCMO | NL58109.078.16 |
| OMON | NL-OMON25998 |