Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

NCT ID: NCT03464175

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-22

Study Completion Date

2020-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Brain Injuries, Traumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Heated-humidifier left on during nebulization

Group Type ACTIVE_COMPARATOR

Aerogen Solo®

Intervention Type DEVICE

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

Heated-humidified circuit

Intervention Type DEVICE

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

Heated-humidifier turned off 30 minutes before nebulization

Group Type ACTIVE_COMPARATOR

Aerogen Solo®

Intervention Type DEVICE

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

Heated-humidified circuit

Intervention Type DEVICE

It will be turned off 30 minutes before the nebulization (nebulization ended max 45 minutes after turning off the heated-humidifier).

Use of a heat and moisture exchanger (HME) filter

Group Type ACTIVE_COMPARATOR

Aerogen Solo®

Intervention Type DEVICE

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

Conventional dry ventilator circuit with HME filter

Intervention Type DEVICE

The nebulizer is placed between the filter and the endotracheal tube.

Use of a dry ventilator circuit specific for aerosol therapy

Group Type ACTIVE_COMPARATOR

Aerogen Solo®

Intervention Type DEVICE

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

Dry ventilator circuit specific for aerosol therapy

Intervention Type DEVICE

Streamlined components, specific position for the nebulizer at 30 cm of a V-shaped Y piece

Interventions

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Aerogen Solo®

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

Intervention Type DEVICE

Heated-humidified circuit

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

Intervention Type DEVICE

Heated-humidified circuit

It will be turned off 30 minutes before the nebulization (nebulization ended max 45 minutes after turning off the heated-humidifier).

Intervention Type DEVICE

Dry ventilator circuit specific for aerosol therapy

Streamlined components, specific position for the nebulizer at 30 cm of a V-shaped Y piece

Intervention Type DEVICE

Conventional dry ventilator circuit with HME filter

The nebulizer is placed between the filter and the endotracheal tube.

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-François Laterre, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universiataires Saint-Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2017/08NOV/508

Identifier Type: -

Identifier Source: org_study_id

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