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

Sponsor

Soroka University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT00320892

Collaborator

Ben-Gurion University of the Negev (Other)

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Noise Death	Drug: Atropine Sulphate 1% ophthalmic drops	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Jun 1, 2012

Outcome Measures

Primary Outcome Measures

Noise Level [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.