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OpenTrials
Completed

NCT Number: NCT03464175

Influence of Respiratory Gases Conditioning on Aerosol Delivery During Invasive Ventilation

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.

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Key information

Conditions

Brain Injuries, Traumatic Brain Diseases Brain Injuries Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universiataires Saint-Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Aerogen Solo®

Device

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

Heated-humidified circuit

Device

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

Dry ventilator circuit specific for aerosol therapy

Device

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

Conventional dry ventilator circuit with HME filter

Device

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

Primary outcomes

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

    Time frame: 45 minutes

    % of the nominal dose.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: Aerovent-

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 13, 2018
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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