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临床试验/NCT03856918
NCT03856918已完成不适用

Optimal Level of Positive End-expiratory Pressure to Reduce Postoperative Atelectasis After Lung Resection With Protective One-lung Ventilation

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2019年5月28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
142
试验地点
1
主要终点
Modified lung ultrasound score

研究概览

简要总结

Protective ventilation strategy has been widely applied in the field of thoracic surgery requiring one-lung ventilation to reduce postoperative pulmonary complications. Low tidal volume, positive end-expiratory pressure (PEEP), and intermittent recruitment maneuver are key components of protective ventilation strategy. Recent evidence suggests that a tidal volume of 4-5 ml/kg should be applied during protective one-lung ventilation. However, optimal level of PEEP is still unclear. This study aims to investigate optimal level of PEEP to minimize postoperative atelectasis by comparing modified lung ultrasound score in patients applied protective one-lung ventilation using PEEP of 3, 6, or 9 cm of water during thoracic surgery.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing Video-assisted Thoracic Surgery under one-lung ventilation

排除标准

  • Moderate to severe obstructive/restrictive pattern in preoperative pulmonary function test
  • Chronic kidney disease
  • Coronary artery disease
  • Pulmonary hypertension
  • Bilateral lung surgery
  • Conversion to thoracotomy
  • American Society of Anesthesiologists physical status IV or more
  • Refusal to participate

研究组 & 干预措施

PEEP 3 cm of water

Experimental

Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 3 cm of water during thoracic surgery.

干预措施: PEEP 3 cm of water (Procedure)

PEEP 6 cm of water

Experimental

Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 6 cm of water during thoracic surgery.

干预措施: PEEP 6 cm of water (Procedure)

PEEP 9 cm of water

Experimental

Patients allocated in this group will be applied protective one-lung ventilation using tidal volume of 5 ml/kg predicted body weight with PEEP of 9 cm of water during thoracic surgery.

干预措施: PEEP 9 cm of water (Procedure)

结局指标

主要结局

Modified lung ultrasound score

时间窗: Postoperative 1 hour

The score is calculated by adding up the 12 individual quadrant scores assessed using lung ultrasound.

次要结局

  • plasma Tumor Necrosis Factor-α(10 minutes after initiation of one-lung ventilation)
  • Intraoperative desaturation(Average time of 60-90 minutes)
  • Intraoperative partial pressure of arterial oxygen/fraction of inspired oxygen ratio(Average time of 60-90 minutes)
  • Postoperative desaturation(Postoperative 24 hours)
  • plasma Interleukin-6(10 minutes after initiation of one-lung ventilation)
  • plasma Interleukin-10(10 minutes after initiation of one-lung ventilation)
  • Postoperative pulmonary complication(Postoperative 7 days)

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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