Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03464175

Acronym

Aerovent-

Enrollment

Registered

2018-03-13

Start date

2018-01-22

Completion date

2020-12-15

Last updated

2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic

Brief 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.

Interventions

DEVICEAerogen Solo®

Aerosol particles are generated by a vibrating-mesh nebulizer specifically designed for mechanical ventilation

DEVICEHeated-humidified circuit

It will be left on during the transfer and the nebulization in group 1

DEVICEDry ventilator circuit specific for aerosol therapy

Streamlined components, specific position for the nebulizer at 30 cm of a V-shaped Y piece

DEVICEConventional dry ventilator circuit with HME filter

The nebulizer is placed between the filter and the endotracheal tube.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.	45 minutes	% of the nominal dose.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026