NCT05361850已完成不适用
Comparison of Deep Versus Awake Tracheal Extubation in Adults
United States Navy2 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2020年8月28日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Aggregate Rate of Airway and Respiratory Complications
研究概览
简要总结
Prospective, randomized, single-blinded controlled study to compare the airway and respiratory complications of deep and awake tracheal extubations in adults.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA physical status classification system for assessing the fitness of patients before surgery 1-3
- •Meeting American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting
- •Adult patients age 18-64
- •Favorable airway examinations (Mallampati 1 or 2, normal mouth opening, and intact neck extension)
- •Scheduled cases in which tracheal intubation and general anesthesia are indicated
排除标准
- •Patients with chronic obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
- •Unfavorable airway examinations (Mallampati 3 or 4, limited mouth opening, and/or inability to extend neck)
- •Full stomach
- •Known difficult intubation or mask ventilation
- •Surgeries of the airway and intrathoracic surgeries
- •Emergent surgeries
- •Case duration >6 hours
- •Pregnancy
- •Patients scheduled to receive a protocolized anesthetic (Enhanced Recovery After Surgery aka ERAS)
- •ASA Physical Status Classification 4 or 5
- •Chronic diseases such as obstructive pulmonary disease, pulmonary hypertension, interstitial lung disease, active respiratory infections, and/or uncontrolled asthma
- •Uncontrolled gastroesophageal reflux disease (heartburn) defined by presence of symptoms despite compliance with appropriate medication regimen
- •Patient scheduled to receive a protocolized anesthetic ie Enhanced Recovery After Anesthesia (ERAS)
- •Surgeries requiring prone positioning
结局指标
主要结局
Aggregate Rate of Airway and Respiratory Complications
时间窗: Peri-extubation period
Coughing, obstruction, apnea, hypoxemia, bronchospasm, laryngospasm, aspiration
次要结局
- Peri-extubation Heart Rate(Peri-extubation period)
- End-of-Surgery to Out-Of-Room Time(From End-of-Surgery Time (defined by surgical dressing application) to Out-of-Room Time (defined by patient physically leaving operating room), up to two hours)
- Peri-extubation Agitation(From ten minutes prior to extubation to transfer time from PACU Phase 1 to PACU Phase 2 (minimum PACU Phase 1 stay 20 minutes))
- Incidence and Severity of Postoperative Sore Throat(At time of transfer from PACU Phase 1 to PACU Phase 2 once PACU Phase 1 discharge criteria met, minimum of twenty minutes)
- Peri-extubation Blood Pressure(Peri-extubation period)
研究者
Michael Andrew Lee
Staff Anesthesiologist
United States Navy
研究点 (2)
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