NCT04302142撤回不适用
Effect of Applying Cuff Air Leak Pressure as Intraoperative Cuff Pressure on Postoperative Complications: Prospective Randomized Control Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Minimum intracuff pressure at which there is no air leak around the cuff.
研究概览
简要总结
The purpose of the study is to achieve effective ventilation with critical intracuff pressure (Pcr) and determine if application of Pcr reduces the risks associated with over-insufflation of endotracheal cuff including postoperative sore throat, cough,nausea, vomiting, aspiration, and pneumonia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective Surgery under general anesthesia requiring endotracheal tube with mechanical ventilation and expected anesthesia duration of at least 2 hours.
- •No contra-indication for intra-operative volume controlled mechanical ventilation
- •Flat supine surgeries without expected positional adjustments
- •American Society of Anesthesiologists (ASA) physical status I-III
排除标准
- •Use of Nitrous Oxide
- •BMI > 40
- •Ventilation through Nasal intubation or Tracheostomy
- •Preexisting sore throat, coughing, nausea/vomiting
- •Recent history of upper respiratory infection
- •Pregnancy
- •Expected to be kept intubated after surgery completion
研究组 & 干预措施
Intervention group
Experimental
干预措施: ventilation with critical intracuff pressure (Pcr) (Device)
Control Group
Placebo Comparator
干预措施: ventilation with critical intracuff pressure (Pcr) (Device)
结局指标
主要结局
Minimum intracuff pressure at which there is no air leak around the cuff.
时间窗: during surgery
次要结局
- Number of patients with postoperative sore throat as measured by a standardized questionnaire(24 hours post extubation)
- Number of patients with postoperative coughing as measured by a standardized questionnaire(24 hours post extubation)
- Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire(24 hours post extubation)
- Number of patients with postoperative aspiration as measured by a standardized questionnaire(24 hours post extubation)
- Number of patients with postoperative sore throat as measured by a standardized questionnaire(30 minutes post extubation)
- Number of patients with postoperative sore throat as measured by a standardized questionnaire(2 hours post extubation)
- Number of patients with postoperative coughing as measured by a standardized questionnaire(30 minutes post extubation)
- Number of patients with postoperative coughing as measured by a standardized questionnaire(2 hours post extubation)
- Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire(30 minutes post extubation)
- Number of patients with postoperative nausea/vomiting as measured by a standardized questionnaire(2 hours post extubation)
- Number of patients with postoperative aspiration as measured by a standardized questionnaire(30 minutes post extubation)
- Number of patients with postoperative aspiration as measured by a standardized questionnaire(2 hours post extubation)
研究者
Yandong Jiang
Visiting Professor
The University of Texas Health Science Center, Houston
研究点 (1)
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