Subglottic stenosis Laryngostenosis
Conditions
Interventions
OFDI system: The OFDI intravascular imaging system "LUNAWAVE" and imaging catheter "FastView" (Terumo Corporation) are used. The purpose of this product is to image and examine the vessel lumen and ve
Tomography, Optical Coherence
Sponsors
Bitoh Yuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following selection criteria and none of the following exclusion criteria will be eligible for inclusion in this clinical study 1. those undergoing rigid bronchoscopy for subglottic stenosis (Myer-Cotton classification Grade I-III) due to clinical necessity. 2. those undergoing airway management with a tracheostomy tube after tracheostomy 3. who are at least 3 years of age at the time of obtaining consent. 4. who understand the content of the examination and the purpose of the research and are able to obtain written consent from themselves or a substitute.
Exclusion criteria
Exclusion criteria: 1. who have a complete obstruction of subglottic space (Myer-Cotton classification Grade IV) or a severe stenotic lesion that is expected to be difficult to pass an OFDI catheter. 2. who are or may be pregnant or breast-feeding. 3. other subjects who are deemed inappropriate as subjects by the principal investigator or a sub-investigator of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success of imaging of subglottic stenosis by OCT. 3/4 circumference of the stenosis is considered technical success when 3/4 circumference of the stenosis can be imaged by OCT. | — |
Secondary
| Measure | Time frame |
|---|---|
| (Efficacy endpoints) Images obtained by rigid bronchoscopy or CT Examination time (Safety endpoints) No adverse events due to OCT imaging or catheterization Catheter failure No occurrence of disease | — |
Contacts
Public ContactYuki Komyo
Kobe University Hospital
Outcome results
None listed