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临床试验/NCT03943433
NCT03943433已完成不适用

The Effect of Oxygen Concentration During Alveolar Recruitment on Absorption Atelectasis

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2019年5月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98
试验地点
1
主要终点
Modified lung ultrasound score

研究概览

简要总结

The purpose of this study is to investigate the effect of oxygen concentration during alveolar recruitment on absorption ateletasis.

研究设计

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

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing laparoscopic obstetric or colon surgery with Trendelenburg position

排除标准

  • American Society of Anesthesiologists physical status IV or more
  • Severe cardiovascular disease
  • Severe chronic obstructive pulmonary disease, emphysema
  • History of pneumothorax, bullae
  • History of lung resection surgery
  • Conversion to laparotomy
  • Refusal to participate

研究组 & 干预措施

FiO2_1.0

Active Comparator

Alveolar recruitment is performed with 100% oxygen concentration at specific time points.

干预措施: FiO2_1.0 (Procedure)

FiO2_0.4

Experimental

Alveolar recruitment is performed with 40% oxygen concentration at specific time points.

干预措施: FiO2_0.4 (Procedure)

结局指标

主要结局

Modified lung ultrasound score

时间窗: Intraoperative (at the end of operation, before emergence)

The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound. Each quadrant score ranges from 0 (minimal atelectasis)\~3 (severe atelectasis), so the maximum total score is 36.

次要结局

  • Modified lung ultrasound score(Postoperative 30 minutes)
  • Intraoperative desaturation(Intraoperative)
  • Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio(Intraoperative (20minutes after each recruitment))
  • Postoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio(Postoperative 30 minutes)
  • Postoperative pulmonary complication(Postoperative 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jae-Hyon Bahk, MD, PhD

Professor

Seoul National University Hospital

研究点 (1)

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