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CompletedNCT03464175Aerovent-Updated Nov 4, 2022

Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

An interventional study of Aerogen Solo® and Heated-humidified circuit in Brain Injuries, Traumatic, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-04.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Injuries, Traumatic
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Heated-humidifier left on during nebulization

    Device: Aerogen Solo® · Device: Heated-humidified circuit

  • Active comparator
    Heated-humidifier turned off 30 minutes before nebulization

    Device: Aerogen Solo® · Device: Heated-humidified circuit

  • Active comparator
    Use of a heat and moisture exchanger (HME) filter

    Device: Aerogen Solo® · Device: Conventional dry ventilator circuit with HME filter

  • Active comparator
    Use of a dry ventilator circuit specific for aerosol therapy

    Device: Aerogen Solo® · Device: Dry ventilator circuit specific for aerosol therapy

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

  • DeviceHeated-humidified circuit

    It will be turned off 30 minutes before the nebulization (nebulization ended max 45 minutes after turning off the heated-humidifier).

  • 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.

05

What researchers measure

Primary outcomes

  1. Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.

    % of the nominal dose.

    Time frame: 45 minutes

06

Study locations

1 site
  • Cliniques Universiataires Saint-Luc
    Bruxelles, 1200, Belgium
07

Registry details

Key details

Study ID
NCT03464175
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible party
Sponsor
First posted
Mar 13, 2018
Start date
Jan 22, 2018
Primary completion
Dec 15, 2020
Completion
Dec 15, 2020
Last update
Nov 4, 2022

Study contacts

Pierre-François Laterre, MD, PhD
principal investigator · Cliniques universitaires Saint-Luc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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