Tracheostomized PatientsNCT01882595
Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
A study testing Nebulization through the tracheostomy and Nebulization through the mouth in people with Tracheostomized Patients, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tracheostomized Patients
- What is being tested?
- Nebulization through the tracheostomy and Nebulization through the mouth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who were likely to require an elective tracheostomy surgery as part as their head and neck surgery
Who cannot join
- Allergy to Aminoglycosides
- Patients who received Aminoglycosides treatment less than one month prior the surgery
- Pectoralis major flap reconstruction
- Latissimus dorsi flap reconstruction
Trial locations and contacts
1 site in 1 country.
About this study
To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.
- Conditions
- Tracheostomized Patients
- Being tested
- Nebulization through the tracheostomy, Nebulization through the mouth
- Keywords
- Nebulization aerosol nebulizer tracheostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulization through the tracheostomyOther
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 mouthOther
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 group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Other: Nebulization through the mouth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amikacin urinary drug concentration
Measured: At each micturition during 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startJan 2009
- Primary completionJan 2009
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheostomized PatientsStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, laurentpitance, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882595
- Sponsor's protocol ID
- Nebu Tracheo
- Status last verified
- Jun 2013
- First submitted
- 18 Jun 2013
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Tracheostomy on Lung Deposition in Spontaneously Breathing Patient
- ClinicalTrials.gov ID
- NCT01882595
- Acronym / sponsor ID
- Nebu Tracheo
- Conditions
- Tracheostomized Patients
- Keywords
- Nebulization aerosol nebulizer tracheostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare lung deposition of amikacin in two settings: spontaneously breathing through a tracheostomy cannula and through the mouth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebulization through the tracheostomy | Experimental | Other: Nebulization through the tracheostomyEach 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) |
| Nebulization through the mouth | Active comparator | Other: Nebulization through the mouthEach 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who were likely to require an elective tracheostomy surgery as part as their head and neck surgery
Key exclusion criteria (4 listed)
- Allergy to Aminoglycosides
- Patients who received Aminoglycosides treatment less than one month prior the surgery
- Pectoralis major flap reconstruction
- Latissimus dorsi flap reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nebulization through the tracheostomyEach 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 tracheostomy |
| Nebulization through the mouthEach 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. | Other | Nebulization through the mouth |
Primary outcome
Amikacin urinary drug concentration
Time frame: At each micturition during 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nebulization through the tracheostomy and Nebulization through the mouth in people with Tracheostomized Patients, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amikacin urinary drug concentration (time frame: At each micturition during 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.