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临床试验/NCT00320892
NCT00320892终止不适用

"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial

Soroka University Medical Center2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2007年1月最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Noise Level

研究概览

简要总结

Dying patients are often unable to clear secretions from their large airways, resulting in noisy breathing usually described as "death rattle." While there is no evidence that patients find this condition disturbing, the noises may be disturbing to the patient's visitors and caregivers who may fear that the patient is choking to death.

In Israel none of the pharmaceutical drugs listed in the literature exist. Thus, Atropine drops which have been noted in the literature as being used, though according to our knowledge no evidence of clinical trials using sublingual Atropine were conducted.

The study is designed as a randomly controlled, double blind crossover trial. The patient will serve as control for himself, as crossover between placebo and drug (randomly chosen) will take place. The administrator of the drug will be blinded to the medication, each time randomly beginning with a different drug (placebo or Atropine).

We will evaluate Atropine Sulphate 1% ophthalmic drops effect on 33 patients using a noise score scale of 0-3. Noise scores will be taken at the start; 30 min after drug/placebo administration and every hour thereafter. After 4-hours crossover will take place and evaluation will follow the same protocol.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • : Patients belonging to Home Palliative Care Unit of Clalit Health Services - Southern District, and the Oncology Department of Soroka University Medical Center and suffering from "death rattle" will be recruited for the study.

排除标准

  • 未提供

结局指标

主要结局

Noise Level

时间窗: 8 hours

30 min after drug administration; and hourly after the initial administration. if needed a repeat dose will be given and the noise score will be evaluated at 30 min; and hourly thereafter. The repeat dose will be left to the nurses' discretion if they thought the rattle to be unacceptable.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pesach Shvartzman

Head Family Medicine Department

Soroka University Medical Center

研究点 (2)

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