Soft Mist Nasal Administration Device for Topical Anaesthesia of the Nasal Cavity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-15

Study Completion Date

2025-04-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia, Local

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Participants are not randomized. A randomization (paper) strategy will be applied to determine which drug will be applied in which nostril

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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NAA with Lidocaine

One 1 ml syringes with lidocaine 2 % will be prepared and connected to the NAA device. The device will be placed in front of a nostril and the subject is asked not to breath until 0,5 ml of lidocaine has been administered. The lidocaine will be sprayed by the attending anaesthesiologist. After a waiting period of 2 minutes another 0,5 ml of lidocaine will be administered (= total of 1 ml lidocaine 2%).

Group Type EXPERIMENTAL

NAA for topical anaesthesia of the nasal cavity

Intervention Type DEVICE

NAA for topical anaesthesia of the nasal cavity

NAA with NaCl 0,9%

One 1 ml syringes with NaCl 0,9 % will be prepared and connected to the NAA device.

The device will be placed in front of the other nostril and the subject is asked not to breath until 0,5 ml of NaCl has been administered. The NaCl will be sprayed by the attending anaesthesiologist. After a waiting period of 2 minutes another 0,5 ml of NaCl will be administered (= total of 1 ml NaCl 0,9%).

Group Type EXPERIMENTAL

NAA for topical anaesthesia of the nasal cavity

Intervention Type DEVICE

NAA for topical anaesthesia of the nasal cavity

Interventions

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NAA for topical anaesthesia of the nasal cavity

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age between 18-60 years
* Lean body weight \>= 50 kg
* ASA physical status 1

Exclusion Criteria

* Inability to cooperate
* History of hepatic, renal and coagulation diseases,
* Respiratory tract pathology
* Obstruction of the nasal passage
* Chronic rhinitis
* Chronic sinusitis
* Pregnancy
* Allergy to amide type of local anaesthetics
* No written informed consent by subject

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes