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

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ClinicalTrials.gov Identifier: NCT00320892
Recruitment Status : Terminated (Difficulties in recruiting appropriate participants to the study)
First Posted : May 3, 2006
Last Update Posted : July 4, 2012
Sponsor:
Collaborator:
Ben-Gurion University of the Negev
Information provided by (Responsible Party):
Pesach Shvartzman, Soroka University Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Noise Death Drug: Atropine Sulphate 1% ophthalmic drops Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: "Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
Study Start Date : January 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Noise


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


Primary Outcome Measures :
  1. Noise Level [ Time Frame: 8 hours ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Pesach Shvartzman, Head Family Medicine Department, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00320892     History of Changes
Other Study ID Numbers: SOR416506CTIL
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012

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

Additional relevant MeSH terms:
Death
Pathologic Processes
Atropine
Ophthalmic Solutions
Adjuvants, Anesthesia
Anti-Arrhythmia 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
Pharmaceutical Solutions