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Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01882595
Enrollment
9
Registered
2013-06-20
Start date
2009-01-31
Completion date
2011-09-30
Last updated
2013-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tracheostomized Patients

Keywords

Nebulization aerosol nebulizer tracheostomy

Brief summary

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

Interventions

OTHERNebulization through the tracheostomy

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.

OTHERNebulization through the mouth

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.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Amikacin urinary drug concentrationAt each micturition during 24 hours

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026