Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.

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Key information

Conditions

Tracheostomized Patients

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires 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

Patient who were likely to require an elective tracheostomy surgery as part as their head and neck surgery

Exclusion criteria

Allergy to Aminoglycosides
Patients who received Aminoglycosides treatment less than one month prior the surgery
Pectoralis major flap reconstruction
Latissimus dorsi flap reconstruction

Treatment and study plan

Nebulization through the tracheostomy

Other

Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The first session was performed prior to tracheostomy removal. During the first nebulization, subjects inhaled the aerosol through the tracheostomy, cuff inflated and inner cannula removed.

Nebulization through the mouth

Other

Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The second nebulization was performed when the tracheostome was totally scarred. During the second nebulization, subjects inhaled the aerosol a mouth piece and wore a nose clip.

Primary outcomes

Amikacin urinary drug concentration

Time frame: At each micturition during 24 hours

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2011
First posted: Jun 20, 2013
Registry last updated: Jun 20, 2013

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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Completed