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Clinical Trials/NCT00320892
NCT00320892TerminatedNot Applicable

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

Soroka University Medical Center1 site in 1 country2 target enrollmentStarted: January 1, 2007Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
2
Locations
1
Primary Endpoint
Noise Level

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Sex
All
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

  • Not provided

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pesach Shvartzman

Head Family Medicine Department

Soroka University Medical Center

Study Sites (1)

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