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

NCT ID: NCT02450279

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-operative Neurosurgery

Keywords

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Aerosol delivery Invasive mechanical ventilation Jet Nebulizer Vibrating-Mesh nebulizer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Nebulization with a vibrating-mesh nebulizer

Nebulization performed with a vibrating-mesh nebulizer

Group Type ACTIVE_COMPARATOR

technetium-99m - Diethylenetriaminepentaacetic acid

Intervention Type DRUG

Vibrating-mesh nebulizer

Intervention Type DEVICE

Planar scintigraphy

Intervention Type OTHER

Preoperative spirometry

Intervention Type OTHER

Nebulization with a jet nebulizer

Nebulization performed with a jet nebulizer

Group Type ACTIVE_COMPARATOR

technetium-99m - Diethylenetriaminepentaacetic acid

Intervention Type DRUG

Jet Nebulizer

Intervention Type DEVICE

Planar scintigraphy

Intervention Type OTHER

Preoperative spirometry

Intervention Type OTHER

Interventions

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technetium-99m - Diethylenetriaminepentaacetic acid

Intervention Type DRUG

Vibrating-mesh nebulizer

Intervention Type DEVICE

Jet Nebulizer

Intervention Type DEVICE

Planar scintigraphy

Intervention Type OTHER

Preoperative spirometry

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Invasive mechanical ventilation
* Healthy lungs

Exclusion Criteria

* Discontinued procedure due to adverse events.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-François Laterre

Role: STUDY_CHAIR

Head of Intensive Care Unit, Cliniques Universitaires Saint-Luc

Locations

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Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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AeroVent-02

Identifier Type: -

Identifier Source: org_study_id