氦氧混合气对成人下气道狭窄患者呼吸的影响
氦氧混合气对成人下气道狭窄患者呼吸做功的影响
Heliox (a mixture of Helium and Oxygen) can reduce the work of breathing in patients with airway stenosis by modifying turbulent flow into laminar flow. The aim of this study was to analyze the effect of Heliox versus conventional oxygen therapy in patients with lower airway stenosis on muscular effort measured by electromyography and diaphragmatic ultrasound, thoracoabdominal synchrony assessed with plethysmographic bands, dyspnea, stridor, oxygen saturation, transcutaneous carbon dioxide value, blood pressure, heart rate and respiratory rate.
研究概览
详细说明
Lower airway stenosis results in increased work of breathing with stridor and dyspnea, as a consequence of the increased resistances caused by the reduction in airway diameter. Airway resistance also depends on the length of the airway and the type of gas flow. Heliox (a mixture of Helium and Oxygen) is a gas less dense than air, which can change the flow from turbulent to laminar, reducing airway resistance by 20 to 40%, and therefore decreasing the work of breathing. Heliox is an inert gas that does not react with biological membranes, so there are few complications associated with its use, the most relevant being hypoxemia when fixed mixtures are not used and the the fraction of inspired oxygen (FiO2) supplied is less than 21%. The aim of the study was to evaluate if during the perioperative period of lower airway stenosis the administration of Heliox compared to oxygen could reduce the work of breathing and improve dyspnea. For this purpose, patients were treated for 30 minutes with Heliox (fixed mixture of 70% helium and 30% oxygen) using a non rebreather mask or reservoir bag versus 30 minutes with oxygen 31% using a Venturi mask.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Madrid
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Madrid、Madrid、西班牙、28041
- Marta Corral Blanco
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients will be recluted from the pneumology outpatient clinic of the Hospital 12 de Octubre
描述
Inclusion Criteria:
- Patients with lower airway stenosis evaluated at the Respiratory Endoscopy Unit of the Hospital Universitario 12 de Octubre on the waiting list for endoscopic intervention on stenosis.
- Stenosis grade ≥ 3 and Borg scale score > 2.
Exclusion Criteria:
- Presence of relevant comorbidities (uncontrolled ischemic heart disease, ventricular dysfunction, pneumopathies with severe respiratory insufficiency, severe pulmonary hypertension).
- Inability to perform the test due to severe dyspnea or need for emergency intervention.
- Patient on continuous mechanical ventilation, invasive or non-invasive.
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Airway Stenosis
Patients with lower airway stenosis on waiting list for endoscopic intervention on stenosis by respiratory endoscopy unit. |
Treatment for 30 minutes with Heliox from a commercial tank (Oxhelⓒ, Air Liquideⓒ) with a fixed mixture of 70% helium and 30% oxygen with non-rebreather mask or reservoir bag at a flow of 12-15 lpm.
其他名称：
Treatment for 30 minutes with oxygen at FiO2 of 31% with Venturi mask.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in Neural Ventilatory Drive (%):
大体时间：30 minutes with Heliox and 30 minutes with Oxygen 31%
|
Percentage over the Root Mean Square peak for parasternal electromyography (EMG): averaged of the square root of the peak value and the area under the curve of parasternal EMG (%RootMeanSquare) adjusted for respiratory frequency, as a surrogate of diaphragmatic EMG, and sternocleidomastoid EMG, which will give us information on accessory muscle activation. |
30 minutes with Heliox and 30 minutes with Oxygen 31%
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Diaphragmatic excursion assessed with ultrasound
大体时间：At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
|
Assessment of muscular effort by measuring the diaphragmatic excursion (mm) at tidal volume and at vital capacity. |
At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
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Thickening fraction of the diaphragm assessed by ultrasound
大体时间：At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
|
Assessment of muscular effort by measuring the thickening fraction of the diaphragm in the apposition zone (%). |
At minute 15 during the Heliox test and at minute 15 during the Oxygen 31% test.
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Changes in thoracoabdominal synchrony
大体时间：Phase angle was calculated from 10 consecutive breaths at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Assessment of thoracoabdominal synchrony using thoracic and abdominal belts by calculating the phase angle with the Lissajoux loop method (plotting abdominal motion on the x-axis against thoracic motion on the y-axis). |
Phase angle was calculated from 10 consecutive breaths at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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|
Borg Scale Dyspnea evolution (points)
大体时间：Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Degree of dyspnea will be determined by this validated scale with a result between 1 and 10 points.0: Not at all 0.5: Very, very light (hardly noticeable) 1: Very light, 2: Light, 3: Moderate , 4: Somewhat intense, 5: Intense, 6: Between 5 and 7, 7: Very intense, 8: Between 7 and 9, 9: Very, very intense (almost maximum ), 10: Maximum |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Oxygen saturation
大体时间：Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Measured by pulse-oximetry |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Transcutaneous partial pressure of carbon dioxide
大体时间：Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Transcutaneous monitor uses a noninvasive technique to measure the skin-surface partial pressure of carbon dioxide (PtcCO2) |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Blood pressure
大体时间：Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Non-invasive measurement with a sphygmomanometer |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Heart rate
大体时间：Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
number of beats per minute |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
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Respiratory rate
大体时间：Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
Number of breaths per minute |
Basal value and at minutes 1, 5, 15 and 30 during the Heliox test and the Oxygen 31% test.
|
合作者和调查者
调查人员
- 首席研究员：Marta Corral Blanco, MD、Hospital 12 de Octubre
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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