DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



"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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017