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

December 2, 2016 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy respiratory function

Exclusion Criteria:

  • Pulmonary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary deposition
Time Frame: Immediately after nebulization by imaging technique, expected average of 15 minutes
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
Time Frame
Three-dimensional penetration index
Time Frame: immediately after the nebulization by imaging assessment, expected average of 30 minutes
immediately after the nebulization by imaging assessment, expected average of 30 minutes

Other Outcome Measures

Outcome Measure
Time Frame
Spirometry
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 24, 2015

First Posted (Estimate)

April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

December 5, 2016

Last Update Submitted That Met QC Criteria

December 2, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Aerospect-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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