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

NCT ID: NCT02429817

Last Updated: 2016-12-05

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

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-12-31

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.

Detailed Description

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Conditions

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Healthy

Keywords

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Pulmonary aerosol distribution SPECT-CT analysis High flow nasal cannula Vibrating-mesh nebulizer Jet nebulizer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Aeroneb Solo

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

Group Type ACTIVE_COMPARATOR

Technetium-99m - Diethylenetriaminepentaacetic acid

Intervention Type DRUG

99mTc-DTPA solution placed on the nebulizer reservoir

Aeroneb Solo

Intervention Type DEVICE

Single photon emission computed tomography

Intervention Type OTHER

Imaging technique to investigate lung aerosol distribution

Spirometry

Intervention Type OTHER

FEV1, FVC assessment

Standard Jet Nebulizer

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

Group Type ACTIVE_COMPARATOR

Technetium-99m - Diethylenetriaminepentaacetic acid

Intervention Type DRUG

99mTc-DTPA solution placed on the nebulizer reservoir

Jet Nebulizer

Intervention Type DEVICE

Single photon emission computed tomography

Intervention Type OTHER

Imaging technique to investigate lung aerosol distribution

Spirometry

Intervention Type OTHER

FEV1, FVC assessment

Interventions

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Technetium-99m - Diethylenetriaminepentaacetic acid

99mTc-DTPA solution placed on the nebulizer reservoir

Intervention Type DRUG

Aeroneb Solo

Intervention Type DEVICE

Jet Nebulizer

Intervention Type DEVICE

Single photon emission computed tomography

Imaging technique to investigate lung aerosol distribution

Intervention Type OTHER

Spirometry

FEV1, FVC assessment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy respiratory function

Exclusion Criteria

* Pulmonary disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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Aerospect-02

Identifier Type: -

Identifier Source: org_study_id