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"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
This study is currently recruiting participants.
Verified by Soroka University Medical Center, March 2008
Sponsors and Collaborators: Soroka University Medical Center
Ben-Gurion University of the Negev
Information provided by: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00320892
  Purpose

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.


Condition Intervention
Noise
Death
Drug: Atropine Sulphate 1% ophthalmic drops

MedlinePlus related topics: Noise
Drug Information available for: Atropine Atropine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study

Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Noise Level

Estimated Enrollment: 33
Study Start Date: January 2007
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00320892

Contacts
Contact: Pesach Shvartzman, MD 972-8-6477429 spesah@bgu.ac.il
Contact: Valentina Semionov, MD 972-8-6477436 : valsem2002@yahoo.com

Locations
Israel
Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care Recruiting
Beer-Sheva, Israel, 653
Contact: Pesach Shvartzman, MD     972-8-6477429        
Principal Investigator: Valentina Semionov, MD            
Sponsors and Collaborators
Soroka University Medical Center
Ben-Gurion University of the Negev
Investigators
Study Chair: Pesach Shvartzman Ben-Gurion University of the Negev
  More Information

Study ID Numbers: SOR416506CTIL
Study First Received: May 1, 2006
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00320892  
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
Death Rattle
Noise level
Primary Care

Study placed in the following topic categories:
Death
Atropine

Additional relevant MeSH terms:
Parasympatholytics
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Cholinergic Agents
Pharmacologic Actions
Muscarinic Antagonists
Adjuvants, Anesthesia
Mydriatics
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009