“Death Rattle” – A Double Blind, Randomly Controlled, Crossover Trial

Overview

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.

Full Title of Study: “”Death Rattle” – A Double Blind, Randomly Controlled, Crossover Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 2009

Interventions

  • Drug: Atropine Sulphate 1% ophthalmic drops
    • Atropine Sulphate 1% ophthalmic drops will be used, by Fisher Pharmaceutical Labs, at a dose of 2 drops per administration

Clinical Trial Outcome Measures

Primary Measures

  • Noise Level
    • Time Frame: 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.

Participating in This Clinical Trial

Inclusion Criteria

  • : 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. Exclusion Criteria:

-

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Soroka University Medical Center
  • Collaborator
    • Ben-Gurion University of the Negev
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pesach Shvartzman, Head Family Medicine Department – Soroka University Medical Center
  • Overall Official(s)
    • Pesach Shvartzman, Study Chair, Ben-Gurion University of the Negev

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