Abstract
BackgroundDeath rattle (DR), caused by mucus in the respiratory tract, occurs in about half of patients who are in the dying phase. Relatives often experience DR as distressing. Anticholinergics are recommended to treat DR, although there is no evidence for the effect of these drugs. Anticholinergic drugs decrease the production of mucus but do not affect existing mucus. We therefore hypothesize that these drugs are more effective when given prophylactically.MethodsWe set up a randomized double-blind, placebo-controlled, multi-center study evaluating the efficacy of prophylactically given subcutaneous scopolaminebutyl for the prevention of DR in the dying phase. The primary outcome is the occurrence of DR defined as grade ≥ 2 according to the scale of Back measured by a nurse at 2 consecutive time points with an interval of 4 h. Secondary outcomes include adverse effects, quality of dying, quality of life in the last three days and bereavement. A sub-study will explore the experience of participating in a clinical trial in the dying phase from the perspective of relatives. Four hospices will include 200 patients.DiscussionThis is the first double-blind placebo-controlled study to prevent DR in patients in the hospice setting. Research in dying patients is challenging. We will apply ethical and organizational strategies as suggested in the literature.Trial registrationThe trial is retrospectively registered in the Dutch Trial register, identifier NTR 6438 June 2017. EudractCT number 2016–002287-14.
Highlights
Death rattle (DR), caused by mucus in the respiratory tract, occurs in about half of patients who are in the dying phase
Death rattle is defined as ‘noisy breathing caused by the presence of mucus in the upper respiratory tract’ [1, 2]
We designed a randomized controlled trial (RCT) to answer our research question: is scopolaminebutyl, when given prophylactically, effective in preventing death rattle? In this paper, we describe the protocol for this study and show how we addressed the medical-ethical rules and Good Clinical Practice guidelines [13] for this vulnerable patient population
Summary
Death rattle (DR), caused by mucus in the respiratory tract, occurs in about half of patients who are in the dying phase. Anticholinergics are recommended to treat DR, there is no evidence for the effect of these drugs. Death rattle is defined as ‘noisy breathing caused by the presence of mucus in the upper respiratory tract’ [1, 2]. This phenomenon is a common symptom in the last days of life, where 12–92% of patients in the dying phase have been reported to develop death rattle [3]. Professionals assume that patients do not experience distress from death rattle because their consciousness is reduced in the dying phase [5]. Sixty-six percent of the relatives of patients who died in a palliative care unit indicated to experience death rattle as “very stressful” and 53% of them said that there is a great need to improve the care for and treatment of death rattle [7]
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