"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
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|ClinicalTrials.gov Identifier: NCT00320892|
Recruitment Status : Terminated (Difficulties in recruiting appropriate participants to the study)
First Posted : May 3, 2006
Last Update Posted : July 4, 2012
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||June 2012|
- 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
- Noise Level [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320892
|Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care|
|Beer-Sheva, Israel, 653|
|Study Chair:||Pesach Shvartzman||Ben-Gurion University of the Negev|