Tomographic Comparison of Aerosol Lung Distribution With Two Nebulizers Through a High Flow Nasal Cannula

Study Overview
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Brief Summary
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Vibrating-mesh nebulizers ensure currently the best deposition output and are recommended in routine use in intensive care unit. However, jet nebulizers remain the most frequently used nebulizers. On a bench study, aerosol delivery through a high flow nasal cannula (HFNC) was increased using a vibrating-mesh nebulizer as compared to a jet nebulizer. Lung distribution of nebulized particles delivered through a HFNC has never been investigated in vivo. The aim of this study was to compare aerosol lung distribution with both nebulizers through a HFNC by SPECT-CT.

Conditions
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Healthy

Intervention / Treatment
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* Drug: Technetium-99m - Diethylenetriaminepentaacetic acid
* Device: Aeroneb Solo
* Device: Jet Nebulizer
* Other: Single photon emission computed tomography
* Other: Spirometry


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy respiratory function Exclusion Criteria: Pulmonary disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aeroneb Solo<br>Subjects inhaled radiolabelled aerosol via the Aeroneb Solo connected to the high flow nasal cannula. | Drug: Technetium-99m - Diethylenetriaminepentaacetic acid<br>* 99mTc-DTPA solution placed on the nebulizer reservoir<br>Device: Aeroneb Solo<br> <br> Other: Single photon emission computed tomography<br>* Imaging technique to investigate lung aerosol distribution<br>Other: Spirometry<br>* FEV1, FVC assessment<br>|
| Active Comparator: Standard Jet Nebulizer<br>Subjects inhaled radiolabelled aerosol via the jet nebulizer connected to the high flow nasal cannula. | Drug: Technetium-99m - Diethylenetriaminepentaacetic acid<br>* 99mTc-DTPA solution placed on the nebulizer reservoir<br>Device: Jet Nebulizer<br> <br> Other: Single photon emission computed tomography<br>* Imaging technique to investigate lung aerosol distribution<br>Other: Spirometry<br>* FEV1, FVC assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary deposition | Single photon emission tomography combined with a CT-scan | Immediately after nebulization by imaging technique, expected average of 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-dimensional penetration index |  | immediately after the nebulization by imaging assessment, expected average of 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Jet nebulizer, Pulmonary aerosol distribution, SPECT-CT analysis, High flow nasal cannula, Vibrating-mesh nebulizer