Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation (Aerovent-)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Brain Injuries, Traumatic

Treatments: Device: Dry ventilator circuit specific for aerosol therapy; Device: Heated-humidified circuit; Device: Conventional dry ventilator circuit with HME filter; Device: Aerogen Solo®

Study type: Interventional

Funder types: Other

Identifiers

NCT03464175

2017/08NOV/508

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

34 participants in 4 patient groups

Heated-humidifier left on during nebulization

Active Comparator group

Treatment:

Device: Aerogen Solo®

Device: Heated-humidified circuit

Device: Heated-humidified circuit

Heated-humidifier turned off 30 minutes before nebulization

Active Comparator group

Treatment:

Device: Aerogen Solo®

Device: Heated-humidified circuit

Device: Heated-humidified circuit

Use of a heat and moisture exchanger (HME) filter

Active Comparator group

Treatment:

Device: Aerogen Solo®

Device: Conventional dry ventilator circuit with HME filter

Use of a dry ventilator circuit specific for aerosol therapy

Active Comparator group

Treatment:

Device: Aerogen Solo®

Device: Dry ventilator circuit specific for aerosol therapy