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临床试验/NCT03894072
NCT03894072已完成不适用

Effect of High Flow Humidified Oxygen on Non-ventilated Lung During Thoracic Surgery: a Cross-over Study Compared With Conventional CPAP (Continuous Positive Airway Pressure)

Mahidol University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2019年3月1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
入组人数
28
试验地点
1
主要终点
Number of participants with improved oxygenation.

研究概览

简要总结

A single institutional cross-over study design to compare between high flow humidified oxygen (HFHO) device versus conventional CPAP for non-ventilated lung during thoracic surgery.

详细描述

The investigators hypothesize that HFHO may be an alternative tool to supply oxygen to non-ventilated lung during one lung ventilation. CPAP can improve oxygenation at a cost of lung hyperinflation which is an unwanted condition during thoracic surgery especially the video-assisted one.

Recruiting adult patients who undergo lung surgeries that requires one-lung ventilation. Exclusion criteria include the followings:-

  1. Emergency case.
  2. Patients with severe COPD(Chronic Obstructive Pulmonary Diseases).
  3. Patients with moderate baseline hypoxemia (SpO2 < 90% on room air).
  4. Patients with severe hemoptysis.
  5. Patients with upper or lower airway abnormalities.
  6. Patients undergo pulmonary lavage.
  7. Patients with known pulmonary hypertension.
  8. Patients with known pulmonary/tracheobronchial infections.
  9. Patients with suspected difficult airway.
  10. Patients with BMI over 35.
  11. Pregnant patients.

Following a standard anesthetic practice. All participants will receive an intravenous based anesthetic with or without regional blocks. The appropriate sized double lumen endobronchial tube will be placed and fiberoptic bronchoscope is used to verify a proper position. Patient will also get an arterial line for frequent ABG (Arterial Blood Gases) samplings.

Computer generated randomization will divide patients into 2 groups. Baseline ABG will be drawn. After one lung ventilation commenced for 20 minutes, the 2nd ABG will be drawn, the surgeon who was blinded to the intervention will evaluate the quality of lung collapse using 5-point Likert scale. Then, patients will either receive a CPAP or HFHO (depends on randomization) for 20 minutes. Up on 1st intervention completion, the 3rd ABG and lung collapse evaluation will be performed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All adult > 18 years of age undergoes lung surgeries that required one-lung ventilation

排除标准

  • •emergency case
  • •severe COPD
  • •moderate baseline hypoxemia
  • •pulmonary hypertension
  • •difficult upper/lower airway
  • •BMI > 35
  • •severe pneumonia
  • •bronchial lavage
  • •massive hemoptysis

研究组 & 干预措施

HFHO-CPAP

Active Comparator

This group will have HFHO before CPAP

干预措施: CPAP (Device)

HFHO-CPAP

Active Comparator

This group will have HFHO before CPAP

干预措施: HFHO (Device)

CPAP-HFHO

Active Comparator

This group will have CPAP and then HFHO

干预措施: CPAP (Device)

CPAP-HFHO

Active Comparator

This group will have CPAP and then HFHO

干预措施: HFHO (Device)

结局指标

主要结局

Number of participants with improved oxygenation.

时间窗: 20 minutes

Improvement of gas exchanges by arterial blood gases

次要结局

  • Quality of lung collapsed.(20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prasert Sawasdiwipachai

Associate professor

Mahidol University

研究点 (1)

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