"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
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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 |
- 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) |
-
Drug: Atropine Sulphate 1% ophthalmic drops
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Israel | |
| Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care | |
| Beer-Sheva, Israel, 653 | |
| 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 May 21, 2013