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

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Unknown status
CT.gov ID
NCT03464175
Collaborator
(none)
40
1
4
18.2
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Supportive Care
Official Title:
Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation: a Randomized Comparative Scintigraphic Study
Actual Study Start Date :
Jan 22, 2018
Anticipated Primary Completion Date :
Jul 31, 2019
Anticipated Study Completion Date :
Jul 31, 2019

Arms and Interventions

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

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 turned off 15 minutes before the transfer in the Nuclear Medicine Department in group 2 (nebulization performed 30 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, integrated T-piece for the nebulizer at 15 cm of the Y piece

Outcome Measures

Primary Outcome Measures

  1. Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy. [45 minutes]

    % of the nominal dose.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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:
  • 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cliniques Universiataires Saint-Luc Bruxelles Belgium 1200

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Pierre-François Laterre, MD, PhD, Cliniques universitaires Saint-Luc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT03464175
Other Study ID Numbers:
  • 2017/08NOV/508
First Posted:
Mar 13, 2018
Last Update Posted:
Mar 19, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2019