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

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02429817
• Other study ID #: Aerospect-02
• Status: Completed
• Phase: N/A
• First received: April 20, 2015
• Last updated: December 2, 2016
• Start date: April 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy respiratory function

Exclusion Criteria:

• Pulmonary disease

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Technetium-99m - Diethylenetriaminepentaacetic acid
99mTc-DTPA solution placed on the nebulizer reservoir

Device:
• Aeroneb Solo

• Jet Nebulizer

Other:
• Single photon emission computed tomography
Imaging technique to investigate lung aerosol distribution
• Spirometry
FEV1, FVC assessment

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Spirometry		Baseline	No
Primary	Pulmonary deposition	Single photon emission tomography combined with a CT-scan	Immediately after nebulization by imaging technique, expected average of 15 minutes	No
Secondary	Three-dimensional penetration index		immediately after the nebulization by imaging assessment, expected average of 30 minutes	No