NCT06144398已完成不适用
Single Use Versus Standard Flexible Bronchoscopes in Interventional Pulmonary Procedures: an Open Label Randomized Controlled Trial
Clinical Hospital Centre Zagreb2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Overall performance
研究概览
简要总结
Single Use Flexible bronchoscopes have gained popularity in recent years and are becoming technologically more advanced. They are widely accepted and used in everyday practice for simple procedures. The aim of this study is to evaluate single use flexible bronchoscopes in more advanced settings, such as interventional pulmonary procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients requiring an interventional pulmonary procedure during the study period
- •Signed informed consent
排除标准
- •Any patient with a contraindication for rigid and/or flexible bronchoscopy
- •Coagulopathy (PV INR > 1.3)
- •Thrombocytopenia (<50x10*9 or anemia (Hgb <80 g/L)
- •DOAC, LMWH or antiplatelet drug therapy
- •Thrombophilia, history of pulmonary embolism or deep vein thrombosis
- •Contraindication for endobronchial application of adrenaline
- •Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
- •Uncontrolled pulmonary hypertension
- •Cardiovascular decompensation
- •Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)
- •Cervical spine instability
结局指标
主要结局
Overall performance
时间窗: through study completion, an average of 12 months
Overall performance of the bronchoscope as graded by the operator (on a scale from 1 to 10; 1 worse, 10 best performance)
次要结局
- Functionality, handle and interface(through study completion, an average of 12 months)
- Suction(through study completion, an average of 12 months)
- Image quality(through study completion, an average of 12 months)
- Bleeding control(through study completion, an average of 12 months)
- Compatibility(through study completion, an average of 12 months)
研究者
Goran Glodić
MD, Principal Investigator
Clinical Hospital Centre Zagreb
研究点 (2)
Loading locations...
相似试验
终止
不适用
Evaluation of a Disposable Flexible Bronchoscope, aScope IVRespiratory InsufficiencyAtelectasisPneumoniaNCT02255838University of Louisville12
Unknown
4 期
A Randomized Single-blind Clinical Trial of the Efficacy and Safety of Remimazolam in Painless BronchoscopyBronchoscopySedationNCT04919174Second Affiliated Hospital, School of Medicine, Zhejiang University364
尚未招募
不适用
Comparison of two methods for giving anaesthesiaCTRI/2021/08/035834Rohilkhand Medical College
已完成
不适用
Comparison of Disposcope Endoscope and Fiberoptic BronchoscopeTherapeutic Procedural ComplicationNCT02669550The First Hospital of Qinhuangdao40
Unknown
不适用
Reusable Flexible Bronchoscopes Versus Single Use Bronchoscopes : a Satisfaction SurveyBronchoscope UsersNCT03392610University Hospital, Limoges500