"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
Information source: Soroka University Medical Center
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Noise; Death
Intervention: Atropine Sulphate 1% ophthalmic drops (Drug)
Phase: N/A
Status: Terminated
Sponsored by: Soroka University Medical Center Official(s) and/or principal investigator(s): Pesach Shvartzman, Study Chair, Affiliation: Ben-Gurion University of the Negev
Summary
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.
Clinical Details
Official title: "Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Primary outcome: Noise Level
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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:
-
Locations and Contacts
Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care, Beer-Sheva 653, Israel
Additional Information
Starting date: January 2007
Last updated: July 3, 2012
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