Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06205680
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2023-12-27
Brief Title:
Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 parametersendpoints
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
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 parametersendpoints
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None