Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation
Aerovent-
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2018
CompletedFirst Submitted
Initial submission to the registry
March 4, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedNovember 4, 2022
November 1, 2022
2.9 years
March 4, 2018
November 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.
% of the nominal dose.
45 minutes
Study Arms (4)
Heated-humidifier left on during nebulization
ACTIVE COMPARATORHeated-humidifier turned off 30 minutes before nebulization
ACTIVE COMPARATORUse of a heat and moisture exchanger (HME) filter
ACTIVE COMPARATORUse of a dry ventilator circuit specific for aerosol therapy
ACTIVE COMPARATORInterventions
Aerosol particles are generated by a vibrating-mesh nebulizer specifically designed for mechanical ventilation
It will be left on during the transfer and the nebulization in group 1
Streamlined components, specific position for the nebulizer at 30 cm of a V-shaped Y piece
The nebulizer is placed between the filter and the endotracheal tube.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cliniques Universiataires Saint-Luc
Brussels, 1200, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pierre-François Laterre, MD, PhD
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2018
First Posted
March 13, 2018
Study Start
January 22, 2018
Primary Completion
December 15, 2020
Study Completion
December 15, 2020
Last Updated
November 4, 2022
Record last verified: 2022-11