Scintigraphic Comparison of Lung Deposition With Two Nebulizers During Invasive Mechanical Ventilation

November 7, 2017 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Many devices are available for nebulising drug solution during invasive mechanical ventilation. Vibrating-mesh nebulizers ensure the highest lung deposition output. A recent international survey on aerosol therapy during mechanical ventilation (Ehrmann et al. 2013) reported that jet nebulizers remained the mostly used.

The aim of this study is to compare lung deposition of a radiolabeled administered with both nebulizers during invasive mechanical ventilation by planar scintigraphy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

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
      • Bruxelles, Belgium
        • 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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Invasive mechanical ventilation
  • Healthy lungs

Exclusion Criteria:

  • Discontinued procedure due to adverse events.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nebulization with a vibrating-mesh nebulizer
Nebulization performed with a vibrating-mesh nebulizer
Drug: technetium-99m - Diethylenetriaminepentaacetic acid
Device: Vibrating-mesh nebulizer
Other: Planar scintigraphy
Other: Preoperative spirometry
Active Comparator: Nebulization with a jet nebulizer
Nebulization performed with a jet nebulizer
Drug: technetium-99m - Diethylenetriaminepentaacetic acid
Other: Planar scintigraphy
Other: Preoperative spirometry
Device: Jet Nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pulmonary deposition
Time Frame: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Immediately after nebulization by imaging assessment, an expected average of 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Penetration index
Time Frame: Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Mechanical ventilation settings
Time Frame: During nebulisation time, an expected average of 15 minutes
During nebulisation time, an expected average of 15 minutes
Lung function
Time Frame: Preoperative assessment, the day before inclusion
Preoperative assessment, the day before inclusion

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

Investigators

  • Study Chair: Pierre-François Laterre, Head of Intensive Care Unit, Cliniques Universitaires Saint-Luc

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

March 1, 2016

Primary Completion (Actual)

November 7, 2017

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 18, 2015

First Posted (Estimate)

May 21, 2015

Study Record Updates

Last Update Posted (Actual)

November 8, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AeroVent-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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