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临床试验/NCT04725318
NCT04725318终止不适用

An Observational Study to Determine Feasibility and Validity of Esophageal and Transpulmonary Pressure Measurements During One Lung Ventilation

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2020年11月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Esophageal Pressure at Lung Collapse

研究概览

简要总结

The investigators will assess the feasibility and validity of esophageal pressure measurements during one-lung ventilation in the lateral position for surgery by comparing to lung collapse estimated from electrical impedance tomography during a PEEP trial.

详细描述

In this prospective cohort study, the investigators will assess the feasibility of esophageal pressure measurements during general anesthesia with one-lung ventilation in patients undergoing non-cardiac intrathoracic surgery, which is typically conducted in the lateral position. The investigators will measure esophageal pressure with an esophageal balloon catheter. The investigators will compare esophageal pressure measurements to lung collapse estimated by Electrical Impedance Tomography (EIT).

Patients will be equipped with the EIT belt before induction of anesthesia, and a one-minute EIT recording during spontaneous breathing will be conducted. Anesthesia will be induced as to institutional standards and upon the discretion of the attending anesthesiologist. After placement of a double-lumen endotracheal tube, the esophageal balloon catheter will be placed.

  • After placement of the esophageal catheter, esophageal pressure, transpulmonary pressure, airway pressure and flow and EIT signal will be recorded ("baseline").
  • When the patient has been positioned for surgery (typically in the lateral position), a second recording of the above parameters is conducted ("lateral"). One-lung ventilation will then be initiated and a third measurement ("OLV") is made.
  • During the third measurement, a decremental positive end-expiratory pressure trial will be conducted to correlate the measured esophageal pressure to the positive end-expiratory pressure where lung collapse is detected from EIT.
  • Before surgery, the EIT belt is opened and removed from the surgical field to avoid interference.
  • If feasible, when surgery is finished, before reversal of neuromuscular blockade and extubation, a final recording of EIT, esophageal pressure, transpulmonary pressure, airway pressure and flow will be conducted.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • adult patients undergoing non-cardiac surgery with OLV

排除标准

  • Active respiratory infection
  • Prior lung resection
  • Prior esophageal/gastric surgery
  • Esophageal varices
  • Patients under effective anticoagulation at time of surgery
  • Pacemaker/ICD
  • Pregnancy
  • Inability to give written informed consent

结局指标

主要结局

Esophageal Pressure at Lung Collapse

时间窗: During one-lung ventilation

Esophageal pressure during one-lung ventilation in the lateral position at beginning lung collapse as measured by electrical impedance tomography during a decremental PEEP titration

次要结局

  • Optimum PEEP(During one-lung ventilation)
  • Esophageal Pressure(During two-lung ventilation in the supine position)
  • Esophageal Pressure(During one-lung ventilation)
  • Esophageal Pressure(During two-lung ventilation in the lateral position)

研究者

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

Maximilian S Schaefer

Associate Professor of Anaesthesia

Beth Israel Deaconess Medical Center

研究点 (1)

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