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Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

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ClinicalTrials.gov Identifier: NCT01882595
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : June 20, 2013
Sponsor:
Information provided by (Responsible Party):
laurentpitance, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

Condition or disease Intervention/treatment Phase
Tracheostomized Patients Other: Nebulization through the tracheostomy Other: Nebulization through the mouth Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
Study Start Date : January 2009
Actual Primary Completion Date : January 2009
Actual Study Completion Date : September 2011

Arm Intervention/treatment
Experimental: Nebulization through the tracheostomy
Each subjects received two nebulization sessions. The first session was performed prior the tracheostomy removal (through the tracheostomy) and the second one when the when the tracheostome was totally scared (through the mouth)
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.

Active Comparator: Nebulization through the mouth
Each subjects received two nebulization sessions. The first session was performed prior the tracheostomy removal (through the tracheostomy) and the second one when the when the tracheostome was totally scared (through the mouth)
Other: 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.




Primary Outcome Measures :
  1. Amikacin urinary drug concentration [ Time Frame: At each micturition during 24 hours ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882595


Locations
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Belgium
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Responsible Party: laurentpitance, Doctor in physiotherapy, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT01882595    
Other Study ID Numbers: Nebu Tracheo
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: June 2013
Keywords provided by laurentpitance, Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
Nebulization aerosol nebulizer tracheostomy
Additional relevant MeSH terms:
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Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes