Tracheal StenosisNCT02796326
Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
A study testing improved tracheal balloon dilatation in people with Tracheal Stenosis, run by University of Cape Town at 1 site in South Africa.
Trial summary
The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tracheal Stenosis
- What is being tested?
- improved tracheal balloon dilatation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Africa
- Study dates
- Oct 2016to 30 Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Symptoms of tracheal or laryngeal stenosis or airway narrowing
- Endoscopic evidence of subglottic or tracheal stenosis
- Able to provide informed consent
Who cannot join
- Refractory stenosis not amenable to balloon dilatation
- Contraindication to balloon dilatation
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.
Read the detailed description
The primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). Secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.
- Conditions
- Tracheal Stenosis
- Being tested
- improved tracheal balloon dilatation
- Keywords
- tracheal stenosis, tracheal dilatation, ventilation
- Medical subject headings
- Tracheal Stenosis, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
improved tracheal balloon dilatationDevice
Also called tracheal balloon dilatation
Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon
| Study group | Role | What they receive |
|---|---|---|
| Dilatation | Experimental | Patients undergoing tracheal dilatation with the study device Receives: Device: improved tracheal balloon dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of peripheral arterial desaturation
Incidence of desaturation below 90% as measured by peripheral pulse oximeter
Measured: During procedure (up to 60 minutes duration)
Time to desaturation
Time to desaturation below 90% as measured by peripheral pulse oximeter
Measured: During procedure (up to 60 minutes duration)
Secondary outcomes (2)
Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading
Describes the stenosis based on the percent relative reduction in cross-sectional area of the subglottis. Four grades of stenosis: grade I lesions have less than 50% obstruction, grade II lesions have 51% to 70% obstruction, grade III lesions have 71% to 99% obstruction, grade IV lesions have no detectable lumen or complete stenosis.
Measured: During procedure (up to 60 minutes duration)
Incidence of major adverse events
Measured: During and within 24 hours of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2016 (estimated)
- Study startOct 2016
- Primary completion30 Jun 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tracheal StenosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ross Hofmeyr, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796326
- Sponsor's protocol ID
- UCTAnaes-2016-01
- Status last verified
- Oct 2017
- First submitted
- 1 Jun 2016
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Endotracheal Balloon Dilator to Improve Patient Oxygenation and Allow Ventilation During Airway Procedures
- ClinicalTrials.gov ID
- NCT02796326
- Acronym / sponsor ID
- UCTAnaes-2016-01
- Conditions
- Tracheal Stenosis
- Keywords
- tracheal stenosis, tracheal dilatation, ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 10 Jun 2016 (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.
The purpose of the study is to prospectively assess the use of a modified tracheal balloon dilator that allows gas flow (oxygenation and ventilation) through the device while inflated during dilatation.
Detailed description
The primary aim is to determine the incidence of, and time to, arterial desaturation (defined as peripheral plethysmography below 90%). Secondary aims include quantitative and qualitative (waveform) end-tidal capnography levels throughout the procedure, quantitative assessment of dilatation, and incidence of adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dilatation | Experimental | Device: improved tracheal balloon dilatationPatients undergoing tracheal dilatation with the study device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years
- Symptoms of tracheal or laryngeal stenosis or airway narrowing
- Endoscopic evidence of subglottic or tracheal stenosis
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Refractory stenosis not amenable to balloon dilatation
- Contraindication to balloon dilatation
- Lack of informed consent
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 |
|---|---|---|
| improved tracheal balloon dilatationAlso: tracheal balloon dilatationTreatment for laryngotracheal stenosis using a modified tracheal dilatation balloon | Device | Dilatation |
Primary outcome
Incidence of peripheral arterial desaturation
Time frame: During procedure (up to 60 minutes duration)
Incidence of desaturation below 90% as measured by peripheral pulse oximeter
Time to desaturation
Time frame: During procedure (up to 60 minutes duration)
Time to desaturation below 90% as measured by peripheral pulse oximeter
2 secondary outcomes
Efficacy of tracheal dilatation by comparison of pre- and post-dilatation Myer-Cotton grading
Time frame: During procedure (up to 60 minutes duration)
Incidence of major adverse events
Time frame: During and within 24 hours of procedure
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 30 Oct 2017.
- Individual participant dataSharing planned: Yes
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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 improved tracheal balloon dilatation in people with Tracheal Stenosis, run by University of Cape Town at 1 site in South Africa.
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 4 inclusion and 3 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 30 Oct 2017. 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 South Africa. 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?
Incidence of peripheral arterial desaturation (time frame: During procedure (up to 60 minutes duration)). The study lists 2 primary outcomes in all. 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 30 Oct 2017.