Does High Flow Nasal Canula (HFNC) Prevent Hypercapnia During EBUS Under Procedural Sedation?
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Inspiratory CO2 at 45 minutes
研究概览
简要总结
High flow nasal cannula (HFNC) is used in interventional procedures to prevent hypoxia during sedation. In patients with a patent airway, HFNC reduces dead space ventilation as well. It is unknown if dead space ventilation is also reduced by HFNC in an EndoBroncheal UltraSound procedure, in which the airway is partially blocked by the endoscope. Especially in patients with Chronic Obstructive Pulmonary Disease (COPD) the partial blocking of the airway may reduce ventilation. If HFNC is able to reduce dead space during an EBUS-procedure, it may facilitate CO2 clearance, which may lead to a reduction in work of breathing.
This study aims to investigate if HFNC reduces dead space ventilation in patients undergoing an EBUS-procedure and if this is flow-dependent.
A randomized, double-blinded, cross-over study is designed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The patient is sedated and the investigators are blinded for the randomization. Only the care provider is aware of the randomisation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with COPD Gold classification 3 or 4
- •Scheduled EBUS with sedation
排除标准
- •Known neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis, dementia, Multiple Sclerosis or Guillain-Barré.
- •Allergy or intolerance for propofol or esketamine
- •Severe pulmonary hypertension (PAPsyst > 60 mmHg)
- •Pregnancy
- •upper airway obstruction, such as subglottic stenosis or obstructing tumors.
结局指标
主要结局
Inspiratory CO2 at 45 minutes
时间窗: at t=45 minutes
Inspiratory CO2, measured at the carinal level
expiratory CO2 at 25 minutes
时间窗: at t=25 minutes
Expiratory CO2, measured at the carinal level
expiratory CO2 at 45 minutes
时间窗: t=45 minutes
Expiratory CO2, measured at the carinal level
Slope of capnography at 45 minutes
时间窗: At t=45 minutes
Angle of the D-E segment (inspiratory slope)
Inspiratory CO2 at 10 minutes (baseline)
时间窗: at t=10 minutes
Inspiratory CO2, measured at the carinal level
Inspiratory CO2 at 25 minutes
时间窗: at=25 minutes
Inspiratory CO2, measured at the carinal level
Slope of capnography at 10 minutes (baseline)
时间窗: At t=10 minutes
Angle of the D-E segment (inspiratory slope)
expiratory CO2 at 10 minutes (baseline)
时间窗: at t=10 minutes
Expiratory CO2, measured at the carinal level
Slope of capnography at 25 minutes
时间窗: At t=25 minutes
Angle of the D-E segment (inspiratory slope)
次要结局
- Respiratory rate(At t=45 minutes)
- The level of HFNC dead space washout(At t=45 minutes)