Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

Study Overview
=================
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.

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

Conditions
-----------------
Brain Injuries, Traumatic

Intervention / Treatment
-----------------
* Device: Aerogen Solo®
* Device: Heated-humidified circuit
* Device: Heated-humidified circuit
* Device: Dry ventilator circuit specific for aerosol therapy
* Device: Conventional dry ventilator circuit with HME filter


Participation Criteria
=================
Eligibility Criteria
-----------------
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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