Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

Not Applicable

Completed

• Conditions: Brain Injuries, Traumatic
• Interventions: Device: Aerogen Solo®; Device: Heated-humidified circuit; Device: Dry ventilator circuit specific for aerosol therapy; Device: Conventional dry ventilator circuit with HME filter

• Registration Number: NCT03464175
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-22
• Study First Submitted: 2018-03-04
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-13
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Use of a dry ventilator circuit specific for aerosol therapy	Aerogen Solo®	-
Heated-humidifier left on during nebulization	Aerogen Solo®	-
Heated-humidifier left on during nebulization	Heated-humidified circuit	-
Use of a dry ventilator circuit specific for aerosol therapy	Dry ventilator circuit specific for aerosol therapy	-
Heated-humidifier turned off 30 minutes before nebulization	Aerogen Solo®	-
Heated-humidifier turned off 30 minutes before nebulization	Heated-humidified circuit	-
Use of a heat and moisture exchanger (HME) filter	Aerogen Solo®	-
Use of a heat and moisture exchanger (HME) filter	Conventional dry ventilator circuit with HME filter	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques Universiataires Saint-Luc; 🇧🇪 Bruxelles, Belgium