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临床试验/NCT02959515
NCT02959515Unknown不适用

The Effects of Different Methods of Non-ventilated Lung Management on Oxygen Delivery (DO2) During One Lung Ventilation (OLV) in the Supine Position for Video Assisted Thoracoscopic (VATS) Atrial Fibrillation Ablation

Centro Cardiologico Monzino1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Oxygen delivery

研究概览

简要总结

The aim of this study is the comparison of oxygen delivery during OLV+capnothorax and OLV+capnothorax and CPAP.

详细描述

One-lung ventilation (OLV) is utilized mainly during thoracic procedures when surgeon needs the lung deflated to expose the surgical field. In this situation both lungs are perfused but only one is ventilated resulting in high grade of shunt and eventually hypoxemia .

Most of thoracic procedures are performed with the pt lying on one side; the deflated lung receive less blood flow both for the gravity and for the hypoxic pulmonary vasoconstriction (HPV) thus reducing the shunt.

If the pt lyes supine, as in VATS atrial fibrillation (AF) surgical ablation, the protective effect of gravity is lost, shunt remains high and severe hypoxemia is common. Some algorithms are used to improve oxygenation during OLV: high fraction of inspired oxygen (FiO2), positive end expiratory pressure (PEEP) on the ventilated lung, continuous positive airway pressure (CPAP) on the deflated lung, but the latter can be used with caution during VATS because of the obstruction of the surgical field. Increasing the pressure in the pleural cavity with carbon dioxyde (CO2) (capnothorax) could decrease the blood flow in the deflated lung, helping in reducing shunt but this is not yet demonstrated and this manouver could decrease cardiac output. The oxygen delivery (DO2) is cardiac output (CO) by oxygen content and during this surgery both these factors could be compromised.

All consecutive pts electively subjected to OLV in supine position for VATS ablation of AF will be enrolled. On the day of surgery pts will be randomly allocated in two groups depending on the management of the non-ventilated lung (capnothorax or capnothorax and CPAP.

Pts in supine position; tracheal intubation with left-sided double lumen tube (DLT) and position confirmed by bronchoscopy. Lungs are initially ventilated with pressure controlled mode (PCV) at a tidal volume (TV) of 7 mL/kg, I:E ratio 1:2, respiratory rate (RR) to obtain a PaCO2 40-45 mmHg, FiO2 =1 and PEEP 5 cm H2O. During OLV inspiratory pressure is reduced to obtain a TV of 5 mL/Kg, maintaining FiO2=1, PEEP 5 cm H2O and adjusting RR to obtain a PaCO2 40-45 mmHg. Capnothorax is obtained by the insufflation of CO2 and maintained at a preset pressure of 10 mmHg. CPAP on the non ventilated lung is set at 10 cm H2O and FiO2=1.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Pts electively subjected to OLV in supine position for VATS ablation of AF and requiring OLV for > 30'

排除标准

  • •Expected difficult positioning of DLT, severe obesity BMI > 35, uncompensated cardiac disease. OLV < 30'.

研究组 & 干预措施

Capnothorax

Active Comparator

Capnothorax is obtained by the insufflation of CO2in the right pleural cavity and maintained at a preset pressure of 10 mmHg .Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded.

干预措施: Capnothorax (Procedure)

Capnothorax and CPAP

Active Comparator

Capnothorax is obtained by the insufflation of CO2in the right pleural cavity and maintained at a preset pressure of 10 mmHg. CPAP on the non ventilated lung is set at 10 cm H2O and FiO2=1. Arterial and central venous blood gasanalyses, hemodynamic and respiratory variables will be recorded.

干预措施: Capnothorax and CPAP (Procedure)

结局指标

主要结局

Oxygen delivery

时间窗: 10 min after institution of capnothotax or capnothorax and CPAP

Oxygen delivery is cardiac output times arterial oxygen content

次要结局

  • Pulmonary shunt(10 min after institution of capnothotax or capnothorax and CPAP)

研究者

发起方
Centro Cardiologico Monzino
申办方类型
Other
责任方
Principal Investigator
主要研究者

luca salvi

Anesthesia & ICU Senior consultant

Centro Cardiologico Monzino

研究点 (1)

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