Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation: a Randomized Comparative Scintigraphic Study

Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation



Sponsors


Source

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

Overall Status

Recruiting

Start Date

2018-01-22

Completion Date

2019-03-31

Primary Completion Date

2019-03-31

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

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

Enrollment

30

Condition


Intervention

Intervention Type

Device

Intervention Name


Description

Aerosol particles are generated by a vibrating-mesh nebulizer specifically designed for mechanical ventilation

Arm Group Label

Use of a heat and moisture exchanger (HME) filter


Intervention Type

Device

Intervention Name


Description

It will be left on during the transfer and the nebulization in group 1

Arm Group Label

Heated-humidifier turned off 30 minutes before nebulization


Intervention Type

Device

Intervention Name


Description

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).

Arm Group Label

Heated-humidifier left on during nebulization



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).

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

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

Overall Contact

Last Name

Pierre-François Laterre, Md, PhD

Phone

0032 2 764 2735

Email

pierre-francois.laterre@uclouvain.be


Location

Facility

Status

Contact

Cliniques Universiataires Saint-Luc
Bruxelles 1200 Belgium
Recruiting
Last Name: Pierre-François Laterre, MD, PhD
Phone: 0032 2 764
Phone Ext: 2735
Email: pierre-francois.laterre@uclouvain.be

Location Countries

Country

Belgium


Verification Date

2018-03-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Number Of Arms

3

Arm Group

Arm Group Label

Heated-humidifier left on during nebulization

Arm Group Type

Active Comparator


Arm Group Label

Heated-humidifier turned off 30 minutes before nebulization

Arm Group Type

Active Comparator


Arm Group Label

Use of a heat and moisture exchanger (HME) filter

Arm Group Type

Experimental



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Jonathan Dugernier, Physiotherapist

Phone

0032 2 764 2735

Email

jonathan.dugernier@uclouvain.be


Acronym

Aerovent-

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Supportive Care

Masking

Double (Participant, Outcomes Assessor)


Study First Submitted

March 4, 2018

Study First Submitted Qc

March 12, 2018

Study First Posted

March 13, 2018

Last Update Submitted

March 16, 2018

Last Update Submitted Qc

March 16, 2018

Last Update Posted

March 19, 2018


ClinicalTrials.gov processed this data on August 24, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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