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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Cliniques Universiataires Saint-Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Pierre-François Laterre, MD, PhD, Cliniques Universitaires Saint-luc

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2018
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: March 4, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 2017/08NOV/508

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No