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临床试验/NCT05914285
NCT05914285进行中(未招募)不适用

Assessment of Salbutamol Effect on Arterial Oxygenation in COPD Patients During One-lung Ventilation

Yonsei University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年4月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
90
试验地点
1
主要终点
PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)

研究概览

简要总结

One-lung ventilation (OLV) is essential part of anesthesia during thoracic procedures. However, OLV induces a drastic increase of intrapulmonary shunt due to maintained pulmonary perfusion through the nonventilated lung, which may result in severe hypoxemia. Although the protective mechanisms of hypoxic pulmonary vasoconstriction favorably modulate pulmonary perfusion to the ventilated lung, the effect is attenuated in patients with history of chronic obstructive pulmonary disease (COPD), which alters compliance of the pulmonary artery.

Salbutamol is a selective short-acting beta2-agonist and when inhaled during OLV, it acts selectively on the pulmonary vasculature reducing pulmonary vascular resistance of well-ventilated lung. We hypothesized that inhaled salbutamol would alleviate ventilation-perfusion mismatch during OLV of COPD patients, and aimed to assess the effects of salbutamol on oxygenation in these patients.

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
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient age 40~80yrs, scheduled for videoscope-assisted pulmonary lobectomy
  • American Society of Anesthesiologists Class III 또는 IV
  • Moderate or more severe COPD according to GOLD criteria (FEV1/FVC<70%, FEV1<80%)

排除标准

  • New York Heart Association class >II
  • AST level ≥100 IU/mL or ALT ≥ level 50 IU/L
  • Creatinine clearance < 30mL/min
  • History of severe coronary artery occlusive disease, unstable angina, or recent myocardial infarction within 6 months
  • History of pulmonary hypertension or pulmonary edema
  • History of cerebrovascular accident within 3 months

研究组 & 干预措施

Control group

Placebo Comparator

Normal saline

干预措施: 5ml of inhaled normal saline (Drug)

Salbutamol group

Experimental

Salbutamol + normal saline

干预措施: 2.5mg (2.5ml) of inhaled salbutamol and 2.5ml of inhaled normal saline (Drug)

结局指标

主要结局

PaO2 (partial pressure of arterial oxygen) to FiO2 (fraction of inspired oxygen) ratio (P/F ratio)

时间窗: Thirty minutes after the completion of drug inhalation

The P/F ratio is a widely-used objective tool to identify hypoxemic respiratory failure when supplemental oxygen has been administered. It can be used to evaluate the effect of salbutamol on oxygenation during OLV.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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