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

NCT00320892 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2012-07-04

No results posted yet for this study

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.

Conditions

  • Noise
  • Death

Interventions

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

Sponsors & Collaborators

  • Ben-Gurion University of the Negev

    collaborator OTHER

  • Soroka University Medical Center

    lead OTHER

Principal Investigators

  • Pesach Shvartzman · Ben-Gurion University of the Negev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2009-12-31
Completion
2012-06-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00320892 on ClinicalTrials.gov