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临床试验/NCT06518239
NCT06518239已完成不适用

Establishing Optimal PEEP Setting for Obese Patients in the Steep Trendelenburg Position: a Pilot Study.

University of Missouri-Columbia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年11月18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
30
试验地点
1
主要终点
Optimal PEEP

研究概览

简要总结

The purpose of this study is to determine whether the Enlight 2100 electrical impedance tomography (EIT) belt can optimize positive end-expiratory pressure (PEEP) during surgery better than standard anesthesia machines.

详细描述

Positive end-expiratory pressure (PEEP) is a measure taken intraoperatively to manage breathing during surgery. The Enlight 2100 is a device that uses electrical impedance tomography (EIT) to measure PEEP and provide a live image of the lungs while a patient is mechanically ventilated. In this study, the investigators will use the Enlight 2100 EIT belt to measure PEEP intraoperatively in order to better optimize PEEP settings for difficult cases.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • •BMI ≥ 40 kg/m2
  • •Age > 18 years
  • •Scheduled for elective laparoscopic abdominal surgery in the steep Trendelenburg position.
  • •Able to provide informed consent.

排除标准

  • •Currently pregnant.
  • •Presence of pacemaker, neurostimulator, spinal cord stimulator, or implantable cardioverter-defibrillator.
  • •Skin ulcerations on upper torso near the belt placement.
  • •Presence of phrenic nerve palsy or other diaphragm conditions.
  • •Thoracic circumference > 134 cm.
  • •Tracheomalacia.
  • •Inability to speak and understand English.

研究组 & 干预措施

PEEP Belt

Experimental

PEEP belt will be placed on the patient intraoperatively. All patients will be monitored using anesthesia machines as standard of care.

干预措施: Peep Belt (Device)

结局指标

主要结局

Optimal PEEP

时间窗: From the time of consent to the end of surgery, assessed up to 24 hours.

Optimal positive end-expiratory pressure (PEEP) measured using the electrical impedance tomography (EIT) belt during surgery.

次要结局

  • Incidence of extubation complications(From the day of surgery to discharge, up to 1 week)
  • Difference between EIT and standard of care measured PEEP(From the time of consent to the end of surgery, assessed up to 24 hours.)
  • Delays in extubation(From the day of surgery to discharge, up to 1 week)

研究者

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

Antoinette Burger

Assistant Professor

University of Missouri-Columbia

研究点 (1)

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