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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00320892
Enrollment
2
Registered
2006-05-03
Start date
2007-01-31
Completion date
2012-06-30
Last updated
2012-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Death, Noise

Keywords

Death Rattle, Noise level, Primary Care

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.

Interventions

DRUGAtropine 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

Ben-Gurion University of the Negev
CollaboratorOTHER
Soroka University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
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

\-

Design outcomes

Primary

MeasureTime frameDescription
Noise Level8 hours30 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026