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Death rattle in the dying phase: is prophylactic treatment useful?

Death rattle in the dying phase: is prophylactic treatment useful? - Reutelen

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON47094
Enrollment
200
Registered
2016-11-17
Start date
2017-04-10
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reutelen in stervensfase, Ademhalingsstelsel Death rattle noisy breething

Interventions

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

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
- 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)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)