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

Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00320892
• Other study ID #: SOR416506CTIL
• Status: Terminated
• Phase: N/A
• First received: May 1, 2006
• Last updated: July 3, 2012
• Start date: January 2007
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Soroka University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2012
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Death
• Noise

Intervention

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

Locations

Country	Name	City	State
Israel	Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care	Beer-Sheva

Sponsors (2)

Lead Sponsor	Collaborator
Soroka University Medical Center	Ben-Gurion University of the Negev

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Noise Level	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.	8 hours	No