Effect of the Topical Application of Anaesthetics With EnkFiberoptic Atomizer on Usage of Anaesthetics and Sedatives During the Bronchoscopy
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Amount of anaesthetics during flexible bronchoscopy
研究概览
简要总结
The aim of this prospective study is to examine the benefits and risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic purposes (seed extraction in unclear infiltrates, interstitial lung disease, unexplained pulmonary opacities, inspection at hemoptysis)
- •patients aged 18 years or above
- •written informed consent prior to study participation
排除标准
- •known allergy to local anesthetics, midazolam or propofol, known epilepsy, known severe neurological or psychiatric disorder, hemodynamic instability with need for vasopressor therapy, acute or chronic decompensated heart failure, respiratory failure with the need for oxygen supplementation of more than 2 l per minute at rest (pO2 > 55 mmHg) or pCO2 > 50 mmHg at ambient air, known upper airway anomalies, surgery or irradiation of the upper airways in the past, contraindication for transbronchial biopsy as published by international guidelines, e. g. bleeding disorders or severe pulmonary hypertension
- •women, who are pregnant or breastfeeding
- •alcohol or drug abuse
- •expected non-compliance
- •patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
- •Participation on another clinical trial within the last 3 months
- •subjects who are committed to an institution and/or penitentiary by judicial or official order.
- •employees of the investigator cooperation companies.
研究组 & 干预措施
Working channel
Patients will receive local anaesthetics via the working channel of the bronchoscope.
干预措施: bronchoscope (Device)
Enk Fiberoptic Atomizer
Patients will receive the local anaesthetics for the flexible bronchoscopy via the nebulizer Enk Fiberoptic Atomizer.
干预措施: Enk Fiberoptic Atomizer (Device)
结局指标
主要结局
Amount of anaesthetics during flexible bronchoscopy
时间窗: one hour
Validation of the total amount of administered propofol (mg) during the flexible bronchoscopy. Usage of sedatives other than propofol (midazolam), total amount of administered lidocaine, duration of bronchoscopy.
次要结局
- pCO2(two hours)