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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

May 1, 2006
May 3, 2006
July 4, 2012
January 2007
December 2009   (Final data collection date for primary outcome measure)
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.
Noise Level
Complete list of historical versions of study NCT00320892 on ClinicalTrials.gov Archive Site
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"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
"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.

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Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Noise
  • Death
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
33
June 2012
December 2009   (Final data collection date for primary outcome measure)

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:

Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00320892
SOR416506CTIL
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Pesach Shvartzman, Soroka University Medical Center
Soroka University Medical Center
Ben-Gurion University of the Negev
Study Chair: Pesach Shvartzman Ben-Gurion University of the Negev
Soroka University Medical Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP