Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity - Trial NCT06205680
Access comprehensive clinical trial information for NCT06205680 through Pure Global AI's free database. This phase not specified trial is sponsored by Radboud University Medical Center and is currently Not yet recruiting. The study focuses on Anesthesia, Local. Target enrollment is 20 participants.
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Study Focus
Sponsor & Location
Radboud University Medical Center
Timeline & Enrollment
N/A
Mar 01, 2024
Aug 01, 2024
Primary Outcome
Level of anesthesia
Summary
Rationale:
 
 Effective and fast topical anesthesia of the nasal mucosa is of paramount importance for
 nasal instrumentation like nasal fiberoptic procedures, awake nasal fiberoptic intubation and
 placement of nasogastric tubes. Conventional topical anesthesia for the nasal mucosa is often
 patchy and not always effective. The investigators hypothesize that topical anesthesia of the
 nasal mucosa with the nasal atomizer adapter (NAA) provides good to excellent nasal topical
 anesthesia with high patient comfort.
 
 Objective: In this study the NAA will be used for nasal topical anesthesia. The investigators
 will evaluate complete anesthesia of the nasal mucosa for nasal instrumentation, the use of
 the NAA and the comfort level for the subjects.
 
 Study design: Interventional study.
 
 Study population: 20 healthy human volunteers, ASA 1, 18-60 years old.
 
 Intervention: Lidocaine 2% will be applied intranasally with the NAA before nasal
 instrumentation. On completion of the procedure the participant and the researcher will be
 asked to complete a feedback form.
 
 Main study parameters/endpoints:
 
 Studying the level of anesthesia of the nasal mucosa as evaluated and demonstrated with
 successful awake nasal instrumentation with minimal discomfort for the subject.
 
 Nature and extent of the burden and risks associated with participation:
 
 Risk management on the nasal atomizer adapter (NAA) shows that all user risks are mitigated
 and no residual risks remain for the use of the device. Testing of the device and the
 application of the device in daily practice has no additional risks than the present
 technique of performing topical anaesthesia of the nasal mucosa.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06205680
Device Trial