"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial

This study has been terminated.
(Difficulties in recruiting appropriate participants to the study)
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00320892
First received: May 1, 2006
Last updated: July 3, 2012
Last verified: July 2012
  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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: January 2007
Study Completion Date: June 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Israel
Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
Beer-Sheva, Israel, 653
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

No publications provided

Responsible Party: Pesach Shvartzman, Head Family Medicine Department, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00320892     History of Changes
Other Study ID Numbers: SOR416506CTIL
Study First Received: May 1, 2006
Last Updated: July 3, 2012
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 22, 2014