"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial|
- Noise Level [ Time Frame: 8 hours ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2007|
|Study Completion Date:||June 2012|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Drug: Atropine Sulphate 1% ophthalmic drops
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320892
|Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care|
|Beer-Sheva, Israel, 653|
|Study Chair:||Pesach Shvartzman||Ben-Gurion University of the Negev|