Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

NCT01882595 | Completed

• 1 other identifier: Nebu Tracheo
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tracheostomized Patients

Keywords

Nebulization aerosol nebulizer tracheostomy

Outcome Measures

Primary Outcomes (1)

• Amikacin urinary drug concentration

  At each micturition during 24 hours

Study Arms (2)

Nebulization through the tracheostomy

EXPERIMENTAL

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

Nebulization through the mouth

ACTIVE COMPARATOR

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

Interventions

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 tracheostomy

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.

Nebulization through the mouth

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor in physiotherapy

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: June 20, 2013
• Study Start: January 1, 2009
• Primary Completion: January 1, 2009
• Study Completion: September 1, 2011
• Last Updated: June 20, 2013

Record last verified: 2013-06

Locations

BE (1)