NCT02429817

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 5, 2016

Status Verified

December 1, 2016

Enrollment Period

1.7 years

First QC Date

April 20, 2015

Last Update Submit

December 2, 2016

Conditions

Healthy

Keywords

Pulmonary aerosol distributionSPECT-CT analysisHigh flow nasal cannulaVibrating-mesh nebulizerJet nebulizer

Outcome Measures

Primary Outcomes (1)

  • Pulmonary deposition

    Single photon emission tomography combined with a CT-scan

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

Secondary Outcomes (1)

  • Three-dimensional penetration index

    immediately after the nebulization by imaging assessment, expected average of 30 minutes

Other Outcomes (1)

  • Spirometry

    Baseline

Study Arms (2)

Aeroneb Solo

ACTIVE COMPARATOR

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

Drug: Technetium-99m - Diethylenetriaminepentaacetic acidDevice: Aeroneb SoloOther: Single photon emission computed tomographyOther: Spirometry

Standard Jet Nebulizer

ACTIVE COMPARATOR

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

Drug: Technetium-99m - Diethylenetriaminepentaacetic acidDevice: Jet NebulizerOther: Single photon emission computed tomographyOther: Spirometry

Interventions

Technetium-99m - Diethylenetriaminepentaacetic acidDRUG

99mTc-DTPA solution placed on the nebulizer reservoir

Aeroneb SoloStandard Jet Nebulizer
Aeroneb SoloDEVICE
Aeroneb Solo
Jet NebulizerDEVICE
Standard Jet Nebulizer
Single photon emission computed tomographyOTHER

Imaging technique to investigate lung aerosol distribution

Aeroneb SoloStandard Jet Nebulizer
SpirometryOTHER

FEV1, FVC assessment

Aeroneb SoloStandard Jet Nebulizer

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy respiratory function

You may not qualify if:

  • Pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 29, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 5, 2016

Record last verified: 2016-12

Locations

BE(1)