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

Post-operative Neurosurgery Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879488
• Other study ID #: AeroVent-01
• Status: Completed
• Phase: N/A
• First received: June 10, 2013
• Last updated: November 16, 2015
• Start date: July 2013
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Invasive mechanical ventilation

• Healthy lungs

Exclusion Criteria:

• Change of ventilation mode during nebulization

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-operative Neurosurgery

Intervention

Drug:
• technetium-99m - Diethylenetriaminepentaacetic acid

Device:
• Vibrating-mesh nebulizer

Other:
• Gamma scintigraphy

• Preoperative spirometry

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

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	No
Secondary	Penetration index		Immediately after nebulization by imaging assessment, an expected average of 30 minutes	No
Secondary	Mechanical ventilation settings		During nebulisation time, an expected average of 15 minutes	No
Secondary	Lung function		Preoperative assessment, the day before inclusion	No