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Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 18, 2013
First Posted Date  ICMJE June 20, 2013
Last Update Posted Date June 20, 2013
Study Start Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Amikacin urinary drug concentration [ Time Frame: At each micturition during 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
Official Title  ICMJE Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
Brief Summary To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Tracheostomized Patients
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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)
    Intervention: Other: Nebulization through the tracheostomy
  • 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)
    Intervention: Other: Nebulization through the mouth
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2013)
9
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01882595
Other Study ID Numbers  ICMJE Nebu Tracheo
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party laurentpitance, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP