Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient

NCT ID: NCT01882595

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-09-30

Brief Summary

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

Conditions

Tracheostomized Patients

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

Nebulization through the tracheostomy

Intervention Type: 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 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)

Group Type: ACTIVE_COMPARATOR

Nebulization through the mouth

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

laurentpitance

Doctor in physiotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Countries

Belgium

Other Identifiers

Nebu Tracheo

Identifier Type: -

Identifier Source: org_study_id