Incidence and Nature of Respiratory Impairment in Consecutive Patients Undergoing Bronchoscopy Under Conscious Sedation: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The incidence of obstructive and central apneic events.
研究概览
简要总结
This study aims to characterize airflow patterns during bronchoscopy under conscious sedation, and determine the incidence of obstructive and central respiratory events. The investigators also plan to monitor the degree and frequency of oxygen desaturation throughout the procedure. To achieve this, investigators use a physiologic monitoring device (NOX T3, K082113) that has been FDA approved for the screening and diagnosis of sleep disordered breathing [1]. The results from this pilot study will be used to assess the feasibility of a prospective study utilizing continuous external negative pressure (Pneuway). This negative pressure is applied through a neck mask to alleviate upper airway collapsibility and can potentially decrease the number of apneas during bronchoscopy under conscious sedation [2].
详细描述
Background and Rationale:
Diagnostic bronchoscopic procedures are commonly performed in patients with various forms of pulmonary disorders associated with abnormal chest imaging. During these procedures, the vocal cords are intubated using a flexible scope. Patients need sedation and analgesia, and conscious sedation is typically administered. Hypoxemia is a potential complication during bronchoscopy. Contributing factors in addition to the underlying lung pathology, include depression of the respiratory center and decreased upper airway muscle tone that occur during conscious sedation [3]. Upper airway obstruction including obstructive apnea is often unrecognized during these procedures till hypoxemia is apparent [4]. Propofol, a common drug used for conscious sedation, is known to cause respiratory depression, and potentially central and/or obstructive apneas with a direct dose-response pattern [5]. Others, including benzodiazepines and opiates, can also cause respiratory depression leading to central or obstructive events. Respiratory depression is potentiated when any of the above medications are combined [6].
Objectives:
The objective of the study is to identify the incidence of airflow limitation during bronchoscopy under conscious sedation, and further characterize it as obstructive or central. The primary endpoint is the incidence of obstructive and central apneic events during bronchoscopic procedures. The secondary outcomes include incidence of oxygen desaturation and need for escalation of care.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with respiratory pathology that require bronchoscopy for further diagnostic evaluation, as part of standard of care
- •Age of 18 years or older.
- •Our study does not include the recruitment of vulnerable populations such as cognitively impaired adults, pregnant women, pregnant minors, minors, wards of the state, non-viable neonates, neonates of uncertain viability and prisoners.
排除标准
- •Oxygen requirement of more than 4 Liter prior to procedure.
- •Intubation or any airway support.
- •Presence of severe cardiopulmonary or neurologic disease as determined by the investigator.
- •Nasal congestion/obstruction preventing proper placement and monitoring of air flow
- •Inability to provide informed consent.
- •All vulnerable population mentioned above.
结局指标
主要结局
The incidence of obstructive and central apneic events.
时间窗: Throughout the bronchoscopic procedure.
Obstructive apnea are defined as more than 90% cessation of air-flow that lasts for at least 10 seconds, despite the presence of respiratory and abdominal muscle effort. Obstructive hypopnea is when more than 30% cessation of air-flow occurs that lasts for at least 10 seconds, and is associated with oxygen desaturation of at least 3% from baseline. Central apnea is when cessation of air-flow occurs secondary to absent respiratory and abdominal muscle effort, that lasts for at least 10 seconds.
次要结局
- Need for escalation of care(Throughout the bronchoscopic procedure.)
- Oxygen desaturation(Throughout the bronchoscopic procedure.)