Effect of Ventilation Mode on Lung Deposition of a Radiolabeled Aerosol During Mechanical Ventilation: Barometric Versus Volumetric

November 16, 2015 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Controlling the respiratory pattern of mechanically ventilated patients in volume control mode is recommended during nebulization. No studies looked into conditions of nebulization during assisted mechanical ventilation to define the optimal nebulization technique and its effect on pulmonary deposition.

The aim of this study is to analyse the effect of ventilation mode (barometric versus volumetric) on deposition by planar scintigraphy during mechanical ventilation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Invasive mechanical ventilation
  • Healthy lungs

Exclusion Criteria:

  • Change of ventilation mode during nebulization

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 during pressure support ventilation
Patients ventilated in pressure support mode during nebulization
Drug: technetium-99m - Diethylenetriaminepentaacetic acid
Device: Vibrating-mesh nebulizer
Other: Preoperative spirometry
Other: Gamma scintigraphy
Active Comparator: Nebulization during volume assist control mode
Patients ventilated in volume assist control mode during nebulization
Drug: technetium-99m - Diethylenetriaminepentaacetic acid
Device: Vibrating-mesh nebulizer
Other: Preoperative spirometry
Other: Gamma scintigraphy

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2013

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

June 10, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AeroVent-01

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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