Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis
Atslēgvārdi
Abstrakts
Apraksts
- Controlled pilot study to determine whether there exists, at a molecular level, a predisposition to the development of tracheomalacia and subglottic stenosis. Thirty patients will be divided into 2 groups of 20 patients (study patients) and 10 patients (control group). Both groups will undergo bronchoscopy and airway biopsy
- The study is a pilot study to evaluate alterations in the airway matrix, growth factor levels, and vascular structures.in patients with tracheobronchomalacia and subglottic stenosis
- Bronchoscopies will be performed in the West Procedure UnitPulmonary Special Procedures Unit or in the operating room (depending on the clinical indication and patient scheduling) at the BIDMC after informed consent is obtained.
- Patients will receive topical upper airway anesthesia with lidocaine and intravenous conscious sedation with fentanyl and midazolam as per standard of care
- Biopsies will be performed according to standard protocols.
- Biopsies will be performed: 2 samples will be sent for pathology as part of clinical care and 2-3 samples used for research analysis.
Datumi
| Pēdējoreiz pārbaudīts: | 02/28/2017 |
| Pirmais iesniegtais: | 06/23/2008 |
| Paredzētā reģistrācija iesniegta: | 06/23/2008 |
| Pirmais izlikts: | 06/25/2008 |
| Pēdējais atjauninājums iesniegts: | 03/16/2017 |
| Pēdējā atjaunināšana ievietota: | 03/20/2017 |
| Faktiskais studiju sākuma datums: | 06/30/2008 |
| Paredzamais primārās pabeigšanas datums: | 03/31/2011 |
| Paredzamais pētījuma pabeigšanas datums: | 03/31/2011 |
Stāvoklis vai slimība
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| 1 10 patients with tracheobronchomalacia | |
| 2 10 patients with tracheal stenosis | |
| 3 10 patients with normal airways (no known airway diseases) |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Paraugu ņemšanas metode | Non-Probability Sample |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | Inclusion Criteria: - (study group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, prior bronchoscopic diagnosis of tracheobronchomalacia, prior bronchoscopic diagnosis of subglottic stenosis (either idiopathic or post-intubation), and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure. - (control group): age ≥ 18, willingness and ability to give informed consent, clinical indication for bronchoscopy and biopsy, no prior diagnosis of any airway disease of any etiology, and smoking cessation for ≥ 4 months. There is no gender or racial restriction. Pregnant women will not be included in the study because of the potential for hypoxemia (especially fetal) and prolongation of the procedure if complications arise. Patients must have family/friends to drive them home following the procedure. Exclusion Criteria: - (study group): pre-existing airway disorders other than tracheobronchomalacia or subglottic stenosis, etiology of subglottic stenosis other than idiopathic or post-intubation, pulmonary vascular disease, inability to tolerate intravenous conscious sedation. - (control group): any pre-existing airway disorder, pulmonary vascular disease, and inability to tolerate intravenous conscious sedation. |
