Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

Tracheostomized Patients Clinical Trial

Official title:

Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882595
• Other study ID #: Nebu Tracheo
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: June 18, 2013
• Start date: January 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2013
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Tracheostomized Patients

Intervention

Other:
• Nebulization 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.
• Nebulization 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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires Saint-Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amikacin urinary drug concentration		At each micturition during 24 hours	No