Matrix Biology of Tracheobronchomalacia and Tracheal Stenosis
キーワード
概要
説明
- 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.
日付
| 最終確認済み: | 02/28/2017 |
| 最初に提出された: | 06/23/2008 |
| 提出された推定登録数: | 06/23/2008 |
| 最初の投稿: | 06/25/2008 |
| 最終更新が送信されました: | 03/16/2017 |
| 最終更新日: | 03/20/2017 |
| 実際の研究開始日: | 06/30/2008 |
| 一次完了予定日: | 03/31/2011 |
| 研究完了予定日: | 03/31/2011 |
状態または病気
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 1 10 patients with tracheobronchomalacia | |
| 2 10 patients with tracheal stenosis | |
| 3 10 patients with normal airways (no known airway diseases) |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| サンプリング方法 | Non-Probability Sample |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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. |
