|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
14 November 2022 |
|
Main ID: |
NCT03464175 |
|
Date of registration:
|
04/03/2018 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation
Aerovent- |
|
Scientific title:
|
Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation: a Randomized Comparative Scintigraphic Study |
|
Date of first enrolment:
|
January 22, 2018 |
|
Target sample size:
|
34 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT03464175 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Belgium
| | | | | | | |
|
Contacts
|
|
Name:
|
Pierre-François Laterre, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Cliniques universitaires Saint-Luc |
| | |
|
Key inclusion & exclusion criteria
|
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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Brain Injuries, Traumatic
|
|
Intervention(s)
|
|
Device: Conventional dry ventilator circuit with HME filter
|
|
Device: Aerogen Solo®
|
|
Device: Dry ventilator circuit specific for aerosol therapy
|
|
Device: Heated-humidified circuit
|
|
Primary Outcome(s)
|
|
Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.
[Time Frame: 45 minutes]
|
|
Secondary ID(s)
|
|
2017/08NOV/508
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|