Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

Brain Injuries, Traumatic Clinical Trial

— Aerovent-  

Official title:

Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation: a Randomized Comparative Scintigraphic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464175
• Other study ID #: 2017/08NOV/508
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: December 15, 2020

Study information

• Verified date: November 2022
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intention is to enroll a specific sample of intubated patients. To compare the effect of respiratory gas conditioning on lung deposition and considering the well-known influences of lung pathology on lung deposition, intubated patients with healthy lungs will be included. Postoperative neurosurgery ventilated patients respond perfectly to this criteria. A previous study including 17 postoperative neurosurgery patients was performed in 2013 with a perfect collaboration between the ICU and the Department of Neurosurgery and Anesthesiology.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or older
• Postoperative neurosurgery intubated patients admitted for brain neurosurgery in the ICU (Intensive care neuro-traumatologic and Toxicologic)- With a healthy lung function.
• Signed and dated informed consent should be obtained in accordance of local regulations.

Exclusion Criteria:

• Spine neurosurgery
• History of cardiovascular and pulmonary disease
• Extubation immediately after surgery
• Modification of the allocated humidification technique before or during the nebulization (heated-humidifier deficiency or safety concern)
• Inaccurate quantification of aerosol deposition (i.e., artifacts or overlap of tracheal and pulmonary deposition).

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic

Intervention

Device:
• Aerogen Solo®
Aerosol particles are generated by a vibrating-mesh nebulizer specifically designed for mechanical ventilation
• Heated-humidified circuit
It will be left on during the transfer and the nebulization in group 1
• Heated-humidified circuit
It will be turned off 30 minutes before the nebulization (nebulization ended max 45 minutes after turning off the heated-humidifier).
• Dry ventilator circuit specific for aerosol therapy
Streamlined components, specific position for the nebulizer at 30 cm of a V-shaped Y piece
• Conventional dry ventilator circuit with HME filter
The nebulizer is placed between the filter and the endotracheal tube.

Locations

Country	Name	City	State
Belgium	Cliniques Universiataires 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	Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.	% of the nominal dose.	45 minutes