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临床试验/NCT04299776
NCT04299776撤回不适用

A Randomized Clinical Trial on the Effects of Active Intrathoracic Pressure Regulation Therapy on Hemodynamic Stability During Shoulder Surgery in the Sitting Position

Zoll Medical Corporation2 个研究点 分布在 1 个国家开始时间: 2020年1月28日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Phenylephrine use

研究概览

简要总结

Intrathoracic pressure regulation (IPR) therapy, delivered by impedance threshold devices (ITDs) or intrathoracic pressure regulators (ITPRs), increases venous return, preload, cardiac output, blood pressure, and cerebral perfusion pressure by intermittently creating negative intrathoracic pressure, which improves circulation in hypotensive animals and humans. By increasing systemic pressure and cerebral perfusion as well as promoting venous return, IPR therapy potentially improves cerebral oxygenation. The lower intrathoracic pressures may also reduce pulmonary artery pressure, although there is currently little evidence one way or the other. Use of an ITPR can counteract the multifactorial intraoperative hypotension common during surgeries under general anesthesia, and reduce the need for other measures to treat such hypotension; however, they might simultaneously promote pulmonary complications.

The investigators will therefore assess whether the use of intrathoracic pressure regulation in adults having shoulder surgery under general anesthesia in the sitting position reduces vasoactive medication requirements compared with routine clinical practice. Simultaneously, the investigators will assess the effect of intrathoracic pressure regulation on pulmonary circulation, cerebral oxygenation, and postoperative atelectasis.

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
Single (Participant)

入排标准

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

入选标准

  • Age ≥18 years
  • American Society of Anesthesiologists (ASA) physical status class ≤3
  • Scheduled for surgery in sitting/ beach-chair positions under general anesthesia in the Cleveland Clinic main campus
  • Planned length of surgery >60 minutes

排除标准

  • Severe peripheral vascular disease or other contraindication for use of vasopressor infusion
  • Obstructive lung disease - moderate or severe asthma or COPD
  • Baseline hypoxemia (SpO2<92% on room air)
  • Body Mass Index (BMI) >35
  • Congestive heart failure
  • Pneumothorax or hemothorax
  • Uncontrolled hemorrhage
  • Planned intraoperative hypotension
  • Contraindication to trans-esophageal echocardiography (esophageal stricture, surgery involving the esophagus or stomach)

结局指标

主要结局

Phenylephrine use

时间窗: from device placement to start of wound closure, a period of up to four hours

Amount of phenylephrine required to maintain MAP of 80±5 mmHg

次要结局

  • Pulmonary artery pressure(at least two minutes after IPR level of -10 cmH2O has been set)
  • Atelectasis(first day post-op)
  • PaO2(at least 20 minutes, but not more than 2 hours, after patient is free of oxygen supplementation)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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