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

Not Applicable

Terminated

• Conditions: Post-operative Neurosurgery
• Interventions: Drug: technetium-99m - Diethylenetriaminepentaacetic acid; Device: Vibrating-mesh nebulizer; Device: Jet Nebulizer; Other: Planar scintigraphy; Other: Preoperative spirometry

• Registration Number: NCT02450279
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-18
• Study First Posted: 2015-05-21
• Study Start: 2016-03
• Status Verified: 2016-12
• Primary Completion: 2017-11-07
• Last Update Submitted: 2017-11-07
• Last Update Posted: 2017-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Invasive mechanical ventilation
• Healthy lungs

Exclusion Criteria

• Discontinued procedure due to adverse events.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulization with a jet nebulizer	Preoperative spirometry	Nebulization performed with a jet nebulizer
Nebulization with a vibrating-mesh nebulizer	Vibrating-mesh nebulizer	Nebulization performed with a vibrating-mesh nebulizer
Nebulization with a vibrating-mesh nebulizer	technetium-99m - Diethylenetriaminepentaacetic acid	Nebulization performed with a vibrating-mesh nebulizer
Nebulization with a vibrating-mesh nebulizer	Preoperative spirometry	Nebulization performed with a vibrating-mesh nebulizer
Nebulization with a jet nebulizer	technetium-99m - Diethylenetriaminepentaacetic acid	Nebulization performed with a jet nebulizer
Nebulization with a jet nebulizer	Jet Nebulizer	Nebulization performed with a jet nebulizer
Nebulization with a jet nebulizer	Planar scintigraphy	Nebulization performed with a jet nebulizer
Nebulization with a vibrating-mesh nebulizer	Planar scintigraphy	Nebulization performed with a vibrating-mesh nebulizer

Primary Outcome Measures

Name	Time	Method
Pulmonary deposition	Immediately after nebulization by imaging assessment, an expected average of 30 minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium