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Clinical Trials/NCT02429817
NCT02429817CompletedNot Applicable

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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country6 target enrollmentStarted: April 2015Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
6
Locations
1
Primary Endpoint
Pulmonary deposition

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy respiratory function

Exclusion Criteria

  • Pulmonary disease

Arms & Interventions

Aeroneb Solo

Active Comparator

Subjects inhaled radiolabelled aerosol via the Aeroneb Solo connected to the high flow nasal cannula.

Intervention: Technetium-99m - Diethylenetriaminepentaacetic acid (Drug)

Aeroneb Solo

Active Comparator

Subjects inhaled radiolabelled aerosol via the Aeroneb Solo connected to the high flow nasal cannula.

Intervention: Aeroneb Solo (Device)

Aeroneb Solo

Active Comparator

Subjects inhaled radiolabelled aerosol via the Aeroneb Solo connected to the high flow nasal cannula.

Intervention: Single photon emission computed tomography (Other)

Aeroneb Solo

Active Comparator

Subjects inhaled radiolabelled aerosol via the Aeroneb Solo connected to the high flow nasal cannula.

Intervention: Spirometry (Other)

Standard Jet Nebulizer

Active Comparator

Subjects inhaled radiolabelled aerosol via the jet nebulizer connected to the high flow nasal cannula.

Intervention: Technetium-99m - Diethylenetriaminepentaacetic acid (Drug)

Standard Jet Nebulizer

Active Comparator

Subjects inhaled radiolabelled aerosol via the jet nebulizer connected to the high flow nasal cannula.

Intervention: Jet Nebulizer (Device)

Standard Jet Nebulizer

Active Comparator

Subjects inhaled radiolabelled aerosol via the jet nebulizer connected to the high flow nasal cannula.

Intervention: Single photon emission computed tomography (Other)

Standard Jet Nebulizer

Active Comparator

Subjects inhaled radiolabelled aerosol via the jet nebulizer connected to the high flow nasal cannula.

Intervention: Spirometry (Other)

Outcomes

Primary Outcomes

Pulmonary deposition

Time Frame: Immediately after nebulization by imaging technique, expected average of 15 minutes

Single photon emission tomography combined with a CT-scan

Secondary Outcomes

  • Three-dimensional penetration index(immediately after the nebulization by imaging assessment, expected average of 30 minutes)

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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