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临床试验/NCT05154617
NCT05154617Unknown不适用

Assessment of Oxygen Delivery as an Early Predictor of Postoperative Pulmonary Complications During One-lung Pulmonary Ventilation in Thoracic Surgery. A Pilot Study

University Health Network, Toronto0 个研究点目标入组 60 人开始时间: 2022年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
主要终点
The primary outcome will be the occurrence of any POPCs within 30 days of surgery.

研究概览

简要总结

This is a simple descriptive pilot study where 60 patients undergoing One-lung ventilation (OLV) for > 120 minutes during esophagectomy will be enrolled to see if the Flo Trac® system can identify hypoxemia earlier than the standard of care monitoring.

详细描述

One-lung ventilation (OLV) is necessary to facilitate surgical exposure in thoracic surgery. OLV can lead to hypoxemia due to the collapse of the non-dependent lung with potentially increased atelectasis in the dependent lung. Hypoxemia, the low oxygen level in the blood, during OLV can be detected by a decrease in arterial hemoglobin oxygen saturation (SaO2) measured by pulse oximetry (SpO2%). Although the incidence of hypoxemia during OLV is currently considered less than 4%, SaO2 is not well correlated to the oxygen supply to the tissues, determined by oxygen delivery (DO2), thus normal values of SaO2 can be associated with abnormal values of DO2 and on the contrary, hypoxemic values of SaO2 can be associated with normal values of DO2. Hypoxemia in patients with cardiovascular, cerebrovascular and/or pulmonary disease leads to an increased risk of complications related to low oxygen supply.

Postoperative pulmonary complications (POPCs) can lead to increased perioperative morbidity and mortality, increased incidence of admission to an intensive care unit, prolonged hospital stay and increased medical cost.

To the best of our knowledge, there are no studies in thoracic surgery, including esophagectomies, where intraoperative Oxygen Delivery (DO2) or DO2 index (DO2i) is used as a strategy for early detection of POPCs. There are also no studies that have determined the critical level of DO2 and DO2i or Percentage of Oxygen Extraction (O2ER) and Percentage of Oxygen Extraction index (O2ERi) in thoracic surgery associated with POPCs.

The aim of this study is to determine if the use of DO2 and DO2i as a continuous non-invasive monitor of oxygen supply to the tissues during OLV, may help us determine the critical DO2 and DO2i to predict POPCs.

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

入选标准

  • Adults ≥ 18 years
  • Esophagectomy surgery requiring one-lung ventilation for > 120 minutes

排除标准

  • Severe heart disease (LVEF (Left ventricle ejection fraction) <50%) and/or Heart failure with CI (cardiac index) <2.5 l/min/m2 or need of vasopressors and/or ionotropic support
  • Genetic alterations of hemoglobin
  • Pregnant patients
  • History of severe restrictive lung disease (such as pulmonary fibrosis with minimal FEV1 of <75% or COPD/emphysema with minimal FEV1 of <50%) which may affect inflation/deflation times
  • Trauma patients requiring VATS/thoracotomy
  • Patient with recent mechanical ventilation support (2 weeks)

结局指标

主要结局

The primary outcome will be the occurrence of any POPCs within 30 days of surgery.

时间窗: 30 days from the day of surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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