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临床试验/NCT01744886
NCT01744886终止不适用

A Comparison of Oxygen Saturation Between Lateral Decubitus Lung Surgery and Port Access Procedures in Dorsal Decubitus

Onze Lieve Vrouw Hospital2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
29
试验地点
2
主要终点
oxygen saturation

研究概览

简要总结

One-lung ventilation (OLV) during thoracic surgery and its effect on oxygen saturation has been discussed in multiple studies. Literature shows different ventilation strategies and possible hypoxemia has been attributed to several issues.

Port-access cardiac surgical procedures ("key hole surgery" including mitral valve repair or prosthesis, tricuspid valve repair or prosthesis, atrial septal defect closure or a combination of these) require the use of OLV as well. Its effect on oxygen saturation has not been studied previously.

The aim of this study is to investigate the effect of extracorporeal circulation (ECC) and patient positioning on oxygen saturation and on the progress of hypoxemia throughout OLV during port-access in comparison to oxygen saturation throughout OLV during lateral decubitus thoracotomies.

详细描述

OLV is a technique that allows isolation of the individual lung under anesthesia. It is required for a number of thoracic surgical procedures as well as port-access procedures.

The use of a double lumen tube allows easy switching from two-lung to single lung ventilation.

For many thoracic operations the patient will be in the lateral decubitus position. The primary physiologic change that takes place on initiation of OLV is the presence of trans-pulmonary shunting, causing impaired oxygenation and occasionally hypoxemia. The degree of shunt is reduced due to the effect of gravity which increases pulmonary blood flow to the dependent lung and it will be further decreased due to a phenomenon termed hypoxic pulmonary vasoconstriction (HPV).

Hypoxemia may occur during OLV in lateral decubitus position due to the restriction of the dependent lung expansion caused by mediastinal weight therefore leading to atelectasis. Increased ventilation pressure and lung volume of the dependent lung impedes perfusion and contributes to hypoxemia.

Presentation of hypoxemia during OLV is multifactorial. It depends on the operation side (OLV better in left thoracotomies), on preoperative lung function [best indicator = Partial Pressure of Oxygen in Arterial Blood (PaO2) divided by Fraction of Inspired Oxygen (FIO2)] and on the distribution of perfusion. The PaO2/FIO2 is the best parameter to describe the full spectrum of ventilation-perfusion abnormalities, independent of the inspired oxygen concentration level.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing lateral decubitus lung surgery or port-access.
  • American Society of Anesthesiologists Physical Status (ASA) II or III.
  • Age between 18-80 years.
  • Patients willing to sign consent.

排除标准

  • Pre-existing interstitial lung disease.
  • Pre-existing obstructive airway disease.
  • Inability or unwillingness of study participant to give written informed consent.
  • Patients expected to have a difficult intubation for anatomical reasons.

结局指标

主要结局

oxygen saturation

时间窗: 20 minutes after initiation of one-lung ventilation

To compare oxygen saturation during one-lung ventilation in patients undergoing lateral decubitus for non-cardiac thoracic surgery, requiring more than 20 minutes of one-lung ventilation using double lumen intubation, versus patients undergoing port-access cardiac surgical procedures.

次要结局

  • oxygen saturation(15 minutes of one-lung ventilation after patient positioning)

研究者

发起方
Onze Lieve Vrouw Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guy CAMMU

MD, PhD, Staff Anesthetist

Onze Lieve Vrouw Hospital

研究点 (2)

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