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临床试验/NCT04253795
NCT04253795暂停不适用

Comparative Study of Nonintubated Anesthesia With Laryngeal Mask Versus Intubated Anesthesia With Double Lumen Tube in Video-assisted Thoracic Surgery

Antalya Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
60
试验地点
1
主要终点
difference in PaO2/FiO2 ratio at the end of the surgery

研究概览

简要总结

The purpose of this study is to compare to the patients undergoing nonintubated general anesthesia with laryngeal mask and undergoing intubated general anesthesia with double-lumen endotracheal intubation in Video-assisted thoracic surgery (VATS).

详细描述

Although general anesthesia with double-lumen intubation is generally mandatory for Video-assisted thoracic surgery procedures intubation with double lumen tube is related to several risks. Nonintubated general anesthesia with laryngeal mask in patients with spontaneous breathing may be an alternative choice for minor VATS procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients undergoing elective minor VATS procedures will be enrolled the study

排除标准

  • •patients <18 years old,
  • •body mass index (BMI)>30 kg/m2,
  • •American Society Association (ASA) Class>3,
  • •heart failure (New York Heart Association class > II),
  • •a history of arrhythmia or treatment with antiarrhythmic drugs,
  • •bradycardia (heart rate (HR) <45 beats min1)
  • •atrioventricular block,
  • •hepatic or renal dysfunction,
  • •coagulopathy,
  • •sleep apnea syndrome

研究组 & 干预措施

Laryngeal mask group (Group 1)

Active Comparator

Laryngeal mask will be placed in the airway by the anesthesiologist. Lung isolation will be achieved with an artificial pneumothorax induced during opening the pleura, which resulted to the collapse of the nondependent lung with the patient's spontaneous breathing

干预措施: Laryngeal mask (Other)

Double lumen tube Group (Group 2)

Active Comparator

After the correct position of double lumen tube will be determined, one lung ventilation will be started. Lung isolation will be achieved by deflation of the nondependent lung.

干预措施: double lumen tube (Other)

结局指标

主要结局

difference in PaO2/FiO2 ratio at the end of the surgery

时间窗: 1 hour

PaO2/FiO2 ratio will be calculated for both groups at the end of the surgery

次要结局

  • Post anesthetic care unit (PACU) time(30 minutes)
  • Surgeon satisfaction(10 minutes)
  • Anesthesia time(20 minutes)
  • Operating room time(1 hour)
  • Patient satisfaction(10 minutes)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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