"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
Primary Purpose
Noise, Death
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Atropine Sulphate 1% ophthalmic drops
Sponsored by
About this trial
This is an interventional treatment trial for Noise focused on measuring Death Rattle, Noise level, Primary Care
Eligibility 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: -
Sites / Locations
- Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
Outcomes
Primary Outcome Measures
Noise Level
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00320892
First Posted
May 1, 2006
Last Updated
July 3, 2012
Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev
1. Study Identification
Unique Protocol Identification Number
NCT00320892
Brief Title
"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
Official Title
"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Why Stopped
Difficulties in recruiting appropriate participants to the study
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soroka University Medical Center
Collaborators
Ben-Gurion University of the Negev
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Noise, Death
Keywords
Death Rattle, Noise level, Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atropine Sulphate 1% ophthalmic drops
Intervention Description
Atropine Sulphate 1% ophthalmic drops will be used, by Fisher Pharmaceutical Labs, at a dose of 2 drops per administration
Primary Outcome Measure Information:
Title
Noise Level
Description
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.
Time Frame
8 hours
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pesach Shvartzman
Organizational Affiliation
Ben-Gurion University of the Negev
Official's Role
Study Chair
Facility Information:
Facility Name
Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
City
Beer-Sheva
ZIP/Postal Code
653
Country
Israel
12. IPD Sharing Statement
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"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
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