The Efficacy and Safety of the Supraglottic Oxygenation Via Nasotracheal Intubation Reduce the Incidence of Hypoxia in Patients Undergoing Sedated Fiberoptic Bronchoscopy.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
研究概览
简要总结
Bronchoscopy is now widely used for the diagnosis and treatment of various respiratory diseases. However, the procedure is highly stimulating and provokes a strong stress response; because the airway is shared, patients are prone to hypoxia. With the growing emphasis on comfortable care, demand for anesthesia during bronchoscopy has increased. Deep sedation is the most common approach, but when administered in the supine position it often causes the tongue base to fall back. Both nasopharyngeal and oropharyngeal airways can relieve this obstruction, yet neither connects seamlessly to an oxygen supply line, resulting in insufficient oxygen delivery.We therefore replaced the nasopharyngeal airway with a wired endotracheal tube (size 4.0 or 4.5) inserted via the nose. This thinner tube couples easily to an oxygen line or ventilator circuit, partially relieves airway obstruction, and allows ample supraglottic oxygenation. The present study was designed to evaluate the feasibility and safety of this modified oxygen-delivery method in patients undergoing deep sedation for bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Undergoing fiberoptic bronchoscopy under deep sedation.
- •Written informed consent obtained from the patient or their legal representative.
- •Clear understanding of, and voluntary participation in, the study, with informed-consent form signed by the patient or their legal representative.
排除标准
- •Age < 18 years
- •BMI > 30 kg/m²
- •Previous history of abnormal recovery from anesthesia/surgery
- •History of recurrent epistaxis, nasal bone fracture, nasal polyps, or sinus surgery
- •Chronic use of opioid analgesics, benzodiazepine hypnotics, or antidepressant medications
- •Known allergy to any of the anesthetic agents employed
- •Anticipated difficult airway
- •Increased intracranial pressure
- •Active upper-respiratory-tract infection of the oral, nasal, or pharyngeal regions
- •Severe cardiac insufficiency (functional capacity < 4 METs)
- •Severe renal failure requiring dialysis prior to surgery
- •Pre-operative oxygen saturation on room air < 92 %
- •Any condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial
研究组 & 干预措施
Supraglottic oxygenation via nasotracheal catheterization Airway Group
In this group, patients received supraglottic oxygen therapy via nasotracheal intubation.
干预措施: wire-reinforced tracheal tube (Device)
结局指标
主要结局
The incidence of hypoxia（75% ≤ SpO2 < 90% for <60 s）
时间窗: Periprocedural
次要结局
- The incidence of sub-clinical respiratory depression(90% ≤ SpO2 < 95%)(Periprocedural)
- The incidence of severe hypoxia(SpO2 < 75% or 75% ≤ SpO2 < 90% for ≥60 s)(Periprocedural)
研究者
Yueying Zheng
Deputy Director of the Anesthesiology Department
First Affiliated Hospital of Zhejiang University