An interventional study of Nebulizer in Acute Respiratory Insufficiency, Chronic Respiratory Insufficiency and Bronchospasm and Obstruction, sponsored by University Hospital St Luc, Brussels. Completed at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-01.
Sponsored by University Hospital St Luc, Brussels · Not applicable, Interventional, and Treatment
The purpose of the study is to compare the pharmacokinetics of nebulized amikacin administered with three vibrating mesh nebulizers coupled with a single limb circuit bilevel ventilator in healthy volunteers. Following our previous in vitro study, our hypotheses are that the pharmacokinetics varies among the devices tested and that a most efficient device can be identified.
44 studies on the registry are indexed under Bronchial Spasm; 4 are open to participants now.
This study's enrollment of 7 is below the median of 70 across 29 interventional studies indexed under Bronchial Spasm.
Browse Bronchial Spasm studies →University Hospital St Luc, Brussels is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Solo nebulizer associated with a bilevel ventilator
Device: Nebulizer
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb Pro nebulizer associated with a bilevel ventilator
Device: Nebulizer
Amikacin (500 mg/4 mL) administered with an Aerogen AeroNeb NIVO nebulizer associated with a bilevel ventilator
Device: Nebulizer
500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds.
Also known as: Vibrating-mesh nebulizers
Pharmacokinetics of nebulized amikacin
The area under the urinary amikacin concentration-time curve after nebulization(AUC0-24 hour) is calculated from the data obtained during 24 hours after nebulization. To determine amikacin absorption during the nebulization, amikacin concentrations are measured in the 24 hours urine collections, which reflected the quantity of dose absorbed via inhalation.
Time frame: within the first 24 hours after nebulization
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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University Hospital St Luc, Brussels