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

Post-operative Neurosurgery Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02450279
• Other study ID #: AeroVent-02
• Status: Terminated
• Phase: N/A
• First received: May 18, 2015
• Last updated: November 7, 2017
• Start date: March 2016

Study information

• Verified date: December 2016
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. primary completion date: November 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Invasive mechanical ventilation

• Healthy lungs

Exclusion Criteria:

• Discontinued procedure due to adverse events.

Related Conditions & MeSH terms

• Post-operative Neurosurgery

Intervention

Drug:
• technetium-99m - Diethylenetriaminepentaacetic acid

Device:
• Vibrating-mesh nebulizer

• Jet Nebulizer

Other:
• Planar scintigraphy

• Preoperative spirometry

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary deposition		Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Secondary	Penetration index		Immediately after nebulization by imaging assessment, an expected average of 30 minutes
Secondary	Mechanical ventilation settings		During nebulisation time, an expected average of 15 minutes
Secondary	Lung function		Preoperative assessment, the day before inclusion