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临床试验/NCT03296449
NCT03296449已完成不适用

Comparison Between Continuous Positive Airway Pressure and High-frequency Jet Ventilation in Nondependent Lung During One-lung Ventilation in Video-assisted Thoracoscopic Surgery

Hospital General Universitario de Alicante2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年11月22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
发起方
入组人数
60
试验地点
2
主要终点
PaO2/FiO2

研究概览

简要总结

This study compares two ventilatory techniques (continuous positive airway pressure vs high frequency jet ventilation) during one-lung ventilation (OLV) in video-assisted thoracic surgery (VATS). All patients were ventilated with both ventilatory techniques and parameters of gas exchange were determined through arterial blood gas test.

详细描述

One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV, collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The use of continuous positive airway pressure on non-dependent lung has become the most common technique to achieve that aim.

High-frequency jet ventilation on non-dependent lung may be considered as an alternative way of ventilation of the non-dependent lung during one-lung ventilation because it provides a suitable gaseous exchange while facilitating minimizing surgical field motion. However, this ventilation maneuver is rarely use by thoracic anesthesiologists.

Over the last years, video assisted thoracic surgery (VATS) has become widely utilized. This surgical technique becomes even more dependent on immobilization of the operation field than open-chest thoracic procedures. There is a lack of evidence in the current literature regarding the use of HFJV in VATS.

The purpose of this study is to evaluate the effects of HFJV as an alternative for the treatment of hypoxemia in VATS.

One-lung ventilation is mandatory during most thoracic surgery procedures. During OLV, collapsed lung develops an intrapulmonary shunt leading to arterial hypoxemia. Since arterial hypoxemia is a critical intraoperative problem, many times , anesthesiologists have to use rescue ventilation strategies on non-dependent lung to improve arterial oxygen levels. The use of continuous positive airway pressure on non-dependent lung has become the most common technique to achieve that aim.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
Triple (Participant, Investigator, Outcomes Assessor)

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

  • Subject requiring one-lung ventilation
  • Subject under video-assisted thoracic surgery

排除标准

  • Emergent surgery
  • Hemodynamic instability

研究组 & 干预措施

One-Lung Ventilation

No Intervention

During one-lung ventilation, when the chest is open, the non-dependent lung is collapsed and manipulated by the surgeon. It is the routine procedure during video-assisted thoracic surgery.

CPAP to non-dependent lung

Active Comparator

The patient will be randomly assigned to the study arm "Continuous Positive Airway Pressure (CPAP)". CPAP will be applied for 20 minutes to the non-dependent lung at a pressure of 2-3cmH20 using the disposable Mallinckrodt Bronchocath CPAP system.

干预措施: CPAP (Procedure)

HFJV to non-dependent lung

Experimental

The patient is randomly assigned to the study arm "High-frequency jet ventilation (HFJV)". HFJV will be applied for 20 minutes to the non-dependent lung with a driving pressure of a 0.6 atm, respiratory rate 100 cycles per minute using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland).

干预措施: HFJV (Procedure)

结局指标

主要结局

PaO2/FiO2

时间窗: 1 day

Ratio of the arterial oxygen partial pressure (PaO2) to the inspired oxygen fraction (FiO2) determination. Time 0 (the patient is anesthetized and being ventilated on two lungs). Time 20 minutes (patient has been ventilated on one lung for 20 minutes). Time 40 minutes (following a period of 20 minutes on one intervention arm \[either CPAP or HFJV\]. The patient will then enter second intervention arm). Time 60 minutes ( 20 minutes after second intervention arm \[either CPAP or HFJV\])

次要结局

  • PaCO2(1 day)
  • Operative field conditions(1 day)

研究者

发起方
Hospital General Universitario de Alicante
申办方类型
Other
责任方
Principal Investigator
主要研究者

María Galiana Ivars

Head of the Section of Clinical Anesthesia and Resuscitation

Hospital General Universitario de Alicante

研究点 (2)

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