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

NCT ID: NCT00320892

Last Updated: 2012-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Noise Death

Keywords

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Death Rattle Noise level Primary Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ben-Gurion University of the Negev

OTHER

Sponsor Role collaborator

Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Pesach Shvartzman

Head Family Medicine Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pesach Shvartzman

Role: STUDY_CHAIR

Ben-Gurion University of the Negev

Locations

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Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care

Beersheba, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SOR416506CTIL

Identifier Type: -

Identifier Source: org_study_id