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临床试验/NCT01407328
NCT01407328已完成不适用

The Effect of the Shoulder Arthroscopic Surgery on Respiratory Mechanics

Samsung Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Static compliance

研究概览

简要总结

During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications. Furthermore, the soft tissue edema around the shoulder may extend to the thoracic cage, compress the chest and induce the respiratory distress immediately after surgery. The investigators attempt to determine the effect of shoulder arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial blood gases were measured and compared before and after the shoulder arthroscopic surgery.

详细描述

Currently, most shoulder surgeries are performed with arthroscopy. The advantages of shoulder arthroscopic surgery are decreased blood loss due to minimal incision for scope, a reduced operation time, minimization of surgical stress, and rapid recovery time after surgery. During shoulder arthroscopic surgery, extravasation of irrigation fluid can occur around the shoulder and trachea, compressing the upper airway. Although the extravasation is generally reabsorbed asymptomatically within 12 hours, there are cases that lead to reintubation or life-threatening complications. Furthermore, the soft tissue edema around the shoulder may extend to the thoracic cage, compress the chest and induce the respiratory distress immediately after surgery. From these facts, the mechanism of respiratory discomfort after shoulder arthroscopic surgery may be because the upper airway obstruction or restrictive pathology due to direct compression of thoracic cage by the soft tissue edema. There have been no studies on the respiratory effect of shoulder arthroscopic surgery. We have observed frequent and severe respiratory discomfort after the shoulder arthroscopic surgery. Therefore, in this study we attempt to determine the effect of shoulder arthroscopic surgery on respiratory mechanics. Changes in respiratory mechanics and arterial blood gases were measured and compared before and after the shoulder arthroscopic surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing arthroscopic shoulder rotator cuff repair surgery
  • American society of anesthesiologist (ASA) class I or II
  • Patients under 70 yrs.

排除标准

  • Patients older than 70 yrs,
  • Patients with anatomical derangement of upper airway,
  • Patients with pulmonary or cardiac disease,
  • Patients with a history of laryngeal or tracheal surgery or hemodynamic instability

结局指标

主要结局

Static compliance

时间窗: before and after arthroscopic surgery, an expected average of 80 minutes

Static compliance (mL/cmH2O) before and after the arthroscopic surgery ,Static compliance = tidal volume delivered / (plateau pressure - PEEP)

dynamic compliance

时间窗: before and after arthroscopic surgery, an expected average of 80 minutes

dynamic compliance (mL/cm H2O) before and after the arthroscpic surgery ,dynamic compliance = tidal volume delivered / (peak pressure - PEEP)

次要结局

  • inspiratory tidal volume(before and after arthroscopic surgery, an expected average of 80 minutes)
  • expiratory tidal volume(before and after arthroscopic surgery, an expected average of 80 minutes)
  • peak inspiratory pressure(before and after arthroscopic surgery, an expected average of 80 minutes)
  • physiologic dead space(before and after arthroscopic surgery, an expected average of 80 minutes)
  • plateau airway pressure(before and after arthroscopic surgery, an expected average of 80 minutes)
  • Mean airway pressure(before and after arthroscopic surgery, an expected average of 80 minutes)
  • positive end expiratory pressure(before and after arthroscopic surgery, an expected average of 80 minutes)
  • inspiratory resistance(before and after arthroscopic surgery, an expected average of 80 minutes)
  • expiratory resistance(before and after arthroscopic surgery, an expected average of 80 minutes)
  • peak inspiratory flow(before and after arthroscopic surgery, an expected average of 80 minutes)
  • peak expiratory flow(before and after arthroscopic surgery, an expected average of 80 minutes)
  • Work of breathing(before and after arthroscopic surgery, an expected average of 80 minutes)
  • end tidal CO2(before and after arthroscopic surgery, an expected average of 80 minutes)
  • arterial oxygen tension(before and after arthroscopic surgery, an expected average of 80 minutes)
  • arterial CO2 tension(before and after arthroscopic surgery, an expected average of 80 minutes)
  • forced vital capacity (FVC)(before and after general anesthesia, an expected average of 120 minutes)
  • forced expiratory volume for 1 second (FEV1)(before and after general anesthesia, an expected average of 120 minutes)

研究者

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

Gwak Mi Sook

Professor

Samsung Medical Center

研究点 (1)

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