NCT02289586Unknown不适用
Interventional Bronchoscopy Under Noninvasive Ventilation for Central Airway Stenosis
Futian People's Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The improvement of partial pressure of arterial oxygen (PaO2) after the operation
研究概览
简要总结
To evaluate the effect and safety of noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis.
With the sedation and analgesia, noninvasive ventilation assisted interventional bronchoscopy for hypoxemia patients with central airway stenosis is safe and effective, carries high satisfaction rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a)patients with central airway stenosis need interventional bronchoscopy. (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
排除标准
- •(a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
研究组 & 干预措施
hypoxemia, central airway stenosis.
Active Comparator
Inclusion Criteria:
- (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Exclusion Criteria:
- (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
干预措施: invasive ventilation (Procedure)
hypoxemia, central airway stenosis.
Active Comparator
Inclusion Criteria:
- (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Exclusion Criteria:
- (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
干预措施: interventional bronchoscopy (Procedure)
hypoxemia, central airway stenosis.
Active Comparator
Inclusion Criteria:
- (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Exclusion Criteria:
- (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
干预措施: general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil） (Drug)
hypoxemia, central airway stenosis
Experimental
Inclusion Criteria:
- (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Exclusion Criteria:
- (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
干预措施: interventional bronchoscopy (Procedure)
hypoxemia, central airway stenosis
Experimental
Inclusion Criteria:
- (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Exclusion Criteria:
- (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
干预措施: noninvasive ventilation (Device)
hypoxemia, central airway stenosis
Experimental
Inclusion Criteria:
- (a)patients with central airway stenosis need interventional bronchoscopy (b) partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 300;
Exclusion Criteria:
- (a) facial deformity sufficient to preclude mask fitting; (b) upper gastrointestinal bleeding; (c) upper airway obstruction; (d) acute coronary syndromes; (e) tracheostomy or endotracheal intubation(ETI) before admission; (f) need for urgent ETI due to cardiac or respiratory arrest.
干预措施: sedation(dezocine and midazolam) (Drug)
结局指标
主要结局
The improvement of partial pressure of arterial oxygen (PaO2) after the operation
时间窗: 1 day
The improvement of airway stenosis after the operation
时间窗: 1 day
次要结局
- hypoxemia during the operation(1 day)
- hospitalization expenses(During the period of hospitalization，an expected average of 4 weeks)
研究者
研究点 (1)
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