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

Primary Purpose

Brain Injuries, Traumatic

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Aerogen Solo®
Heated-humidified circuit
Heated-humidified circuit
Dry ventilator circuit specific for aerosol therapy
Conventional dry ventilator circuit with HME filter
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Injuries, Traumatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Cliniques Universiataires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Heated-humidifier left on during nebulization

Heated-humidifier turned off 30 minutes before nebulization

Use of a heat and moisture exchanger (HME) filter

Use of a dry ventilator circuit specific for aerosol therapy

Arm Description

Outcomes

Primary Outcome Measures

Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.
% of the nominal dose.

Secondary Outcome Measures

Full Information

First Posted
March 4, 2018
Last Updated
November 2, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03464175
Brief Title
Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation
Acronym
Aerovent-
Official Title
Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation: a Randomized Comparative Scintigraphic Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2018 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heated-humidifier left on during nebulization
Arm Type
Active Comparator
Arm Title
Heated-humidifier turned off 30 minutes before nebulization
Arm Type
Active Comparator
Arm Title
Use of a heat and moisture exchanger (HME) filter
Arm Type
Active Comparator
Arm Title
Use of a dry ventilator circuit specific for aerosol therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Aerogen Solo®
Intervention Description
Aerosol particles are generated by a vibrating-mesh nebulizer specifically designed for mechanical ventilation
Intervention Type
Device
Intervention Name(s)
Heated-humidified circuit
Intervention Description
It will be left on during the transfer and the nebulization in group 1
Intervention Type
Device
Intervention Name(s)
Heated-humidified circuit
Intervention Description
It will be turned off 30 minutes before the nebulization (nebulization ended max 45 minutes after turning off the heated-humidifier).
Intervention Type
Device
Intervention Name(s)
Dry ventilator circuit specific for aerosol therapy
Intervention Description
Streamlined components, specific position for the nebulizer at 30 cm of a V-shaped Y piece
Intervention Type
Device
Intervention Name(s)
Conventional dry ventilator circuit with HME filter
Intervention Description
The nebulizer is placed between the filter and the endotracheal tube.
Primary Outcome Measure Information:
Title
Quantity of aerosol deposition from the nebulizer reservoir to the subject. Measured by Planar scintigraphy.
Description
% of the nominal dose.
Time Frame
45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-François Laterre, MD, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universiataires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

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Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

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