Effects of Non-invasive Ventilation With Helium-oxygen Mixture in Premature Infants With Respiratory Distress Syndrome on Pulmonary Function and Electric Activity of the Diaphragm
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox
研究概览
简要总结
The use of a mixture of helium with oxygen (heliox) as a breathing gas may be beneficial due to its unique physical properties, such as low density and high carbon dioxide (CO2) diffusion coefficient. In previous studies in neonates with respiratory failure, conventional ventilation with heliox was associated with improved oxygenation and selected respiratory parameters. The use of heliox may increase the effectiveness of intermittent nasal positive pressure ventilation (NIPPV), but knowledge about the effects of such therapy on newborns is limited.The use of non- invasive neurally adjusted ventilatory assist (NIV-NAVA) allows synchronization and assessment of electrical activity of the diaphragm (EaDI) during heliox administration in premature babies with respiratory failure.
详细描述
Aim of the study was to assess of the impact of non-invasive ventilation with heliox on respiratory function, diaphragm bioelectrical activity, cerebral oxygenation and selected vital signs in premature neonates with respiratory failure. 23 neonates ≤32 weeks gestational age (GA) were enrolled in the study. Patients were eligible for inclusion when ventilated due to respiratory failure, and in group 1 (n=12) on NIV as primary modality with oxygen requirement of 0.25-0.4 in the first 72 hours of life, or in group 2 (n=11) ready to extubate according to the given criteria. Newborns were ventilated with NIV NAVA and standard breathing gas (air-oxygen) at baseline. Heliox was introduced for 3 hours, followed by 3 hours of air-oxygen. NAVA level was kept constant and pulse oximeter oxygen saturation (SpO2) kept in range of 90-95%. Recorded parameters included heart rate (HR), SpO2 and cerebral tissue oxygenation (StO2). Selected ventilation parameters: peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), mean airway pressure (MAP), air leakage during NIV, fraction of inspired oxygen (FiO2) as well as electrical activity of the diaphragm (EaDI mean, minimum and maximum) were also acquired. Blood gas analysis was performed in each period of the study. Statistical analysis was completed with ANOVA Friedman's test and single-factor repeated-measures analysis of variance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Major congenital anomalies
- •Deteriorating pulmonary function despite NIV and the need for intubation and conventional mechanical ventilation (CMV) (Preliminary criteria: pH< 7.22, carbon dioxide partial pressure (pCO2) >65)
研究组 & 干预措施
Group 1
premature infants born < 33 G.A. enrolled in the first 72 hours after birth, with respiratory distress syndrome, requiring non-invasive ventilation with FiO2 <0.4
干预措施: heliox (Drug)
Group 2
premature infants born < 33 G.A. with respiratory insufficiency requiring mechanical ventilation, after more than 1 failed extubation attempt
干预措施: heliox (Drug)
结局指标
主要结局
maximal electric activity of the diaphragm (EaDI max) after 180 minutes of heliox
时间窗: measured after 180 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 15 minutes of standard mixture
时间窗: measured after 15 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 15 minutes of standard mixture
时间窗: measured after 15 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
baseline minimal electric activity of the diaphragm (EaDI min)
时间窗: measured at baseline
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min \[mcV, microvolts\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
baseline mean electric activity of the diaphragm (EaDI mean)
时间窗: measured at baseline
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
baseline maximal electric activity of the diaphragm (EaDI max)
时间窗: measured at baseline
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 15 minutes of heliox
时间窗: measured after 15 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 15 minutes of heliox
时间窗: measured after 15 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 15 minutes of heliox
时间窗: measured after 15 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 60 minutes of heliox
时间窗: measured after 60 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 60 minutes of heliox
时间窗: measured after 60 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 60 minutes of heliox
时间窗: measured after 60 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 180 minutes of heliox
时间窗: measured after 180 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 180 minutes of heliox
时间窗: measured after 180 minutes of heliox ventilation
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 60 minutes of standard mixture
时间窗: measured after 60 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 15 minutes of standard mixture
时间窗: measured after 15 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 60 minutes of standard mixture
时间窗: measured after 60 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 60 minutes of standard mixture
时间窗: measured after 60 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
minimal electric activity of the diaphragm (EaDI min) after 180 minutes of standard mixture
时间窗: measured after 180 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI min \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
mean electric activity of the diaphragm (EaDI mean) after 180 minutes of standard mixture
时间窗: measured after 180 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI mean \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
maximal electric activity of the diaphragm (EaDI max) after 180 minutes of standard mixture
时间窗: measured after 180 minutes since the return to ventilation with standard mixture
Using the NAVA (neurally adjusted ventilatory assist) module of the Maquet Servo-i ventilator and "Servo-tracker" software EaDI max \[mcV\] values will be recorded during the study and their values will be compared between the heliox and air-oxygen NIV (non -invasive ventilation).
baseline MAP (mean airway pressure)
时间窗: measured at baseline
MAP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 15 minutes of heliox
时间窗: measured after 15 minutes of heliox ventilation
PIP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 60 minutes of heliox
时间窗: measured after 60 minutes of heliox ventilation
PIP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 180 minutes of heliox
时间窗: measured after 180 minutes of heliox ventilation
PIP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 15 minutes of standard mixture
时间窗: measured after 15 minutes since the return to ventilation with standard mixture
PIP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
baseline PIP (peak inspiratory pressure)
时间窗: measured at baseline
PIP \[cm H2O, centimeters of water\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
baseline PEEP (positive end-expiratory pressure)
时间窗: measured at baseline
PEEP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 60 minutes of standard mixture
时间窗: measured after 60 minutes since the return to ventilation with standard mixture
PIP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 15 minutes of standard mixture
时间窗: measured after 15 minutes since the return to ventilation with standard mixture
PEEP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PIP (peak inspiratory pressure) after 180 minutes of standard mixture
时间窗: measured after 180 minutes since the return to ventilation with standard mixture
PIP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 15 minutes of heliox
时间窗: measured after 15 minutes of heliox ventilation
PEEP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 60 minutes of heliox
时间窗: measured after 60 minutes of heliox ventilation
PEEP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 180 minutes of heliox
时间窗: measured after 180 minutes of heliox ventilation
PEEP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 60 minutes of standard mixture
时间窗: measured after 60 minutes since the return to ventilation with standard mixture
PEEP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
PEEP (positive end-expiratory pressure) after 180 minutes of standard mixture
时间窗: measured after 180 minutes since the return to ventilation with standard mixture
PEEP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 15 minutes of heliox
时间窗: measured after 15 minutes of heliox ventilation
MAP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 60 minutes of heliox
时间窗: measured after 60 minutes of heliox ventilation
MAP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 180 minutes of heliox
时间窗: measured after 180 minutes of heliox ventilation
MAP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 60 minutes of standard ventilation
时间窗: measured after 60 minutes since the return to ventilation with standard mixture
MAP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 180 minutes of standard ventilation
时间窗: measured after 180 minutes since the return to ventilation with standard mixture
MAP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 15 minutes of heliox
时间窗: measured after 15 minutes of heliox ventilation
gas leakage fraction \[%\] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
baseline NIV leakage
时间窗: measured at baseline
gas leakage fraction \[%\] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
MAP (mean airway pressure) after 15 minutes of standard ventilation
时间窗: measured after 180 minutes since the return to ventilation with standard mixture
MAP \[cm of water / cm H2O\] will be recorded by Servo-tracker software and the values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 60 minutes of heliox
时间窗: measured after 60 minutes of heliox ventilation
gas leakage fraction \[%\] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 180 minutes of heliox
时间窗: measured after 180 minutes of heliox ventilation
gas leakage fraction \[%\] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 15 minutes of standard mixture
时间窗: measured after 15 minutes since the return to ventilation with standard mixture
gas leakage fraction \[%\] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 60 minutes of standard mixture
时间窗: measured after 60 minutes since the return to ventilation with standard mixture
gas leakage fraction \[%\] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
NIV leakage after 180 minutes of standard mixture
时间窗: measured after 180 minutes since the return to ventilation with standard mixture
gas leakage fraction \[%\] during NIV (non-invasive ventilation) recorded by Servo-tracker software their values will be compared between the heliox and air-oxygen NIV.
次要结局
- Cerebral oxygenation after 180 minutes of standard mixture(measured after 180 minutes since the return to standard mixture ventilation)
- baseline cerebral oxygenation(measured at baseline)
- Cerebral oxygenation after 15 minutes of heliox(measured after 15 minutes of heliox ventilation)
- Cerebral oxygenation after 60 minutes of heliox(measured after 60 minutes of heliox ventilation)
- Cerebral oxygenation after 180 minutes of heliox(measured after 180 minutes of heliox ventilation)
- Cerebral oxygenation after 15 minutes of standard mixture(measured after 15 minutes since the return to standard mixture ventilation)
- Cerebral oxygenation after 60 minutes of standard mixture(measured after 60 minutes since the return to standard mixture ventilation)
- baseline oxygen requirements(recorded at baseline)
- heart rate after 15 minutes of heliox(measured after 15 minutes of heliox ventilation)
- heart rate after 60 minutes of heliox(measured after 60 minutes of heliox ventilation)
- heart rate after 180 minutes of heliox(measured after 180 minutes of heliox ventilation)
- heart rate after 15 minutes of standard mixture(measured after 15 minutes since the return to standard mixture ventilation)
- heart rate after 60 minutes of standard mixture(measured after 60 minutes since the return to standard mixture ventilation)
- oxygen requirements after 15 minutes of heliox(recorded after 15 minutes of heliox ventilation)
- oxygen requirements after 60 minutes of heliox(recorded after 60 minutes of heliox ventilation)
- oxygen requirements after 180 minutes of heliox(recorded after 180 minutes of heliox ventilation)
- oxygen requirements after 15 minutes of standard ventilation(recorded after 15 minutes since the return to standard mixture ventilation)
- oxygen requirements after 60 minutes of standard ventilation(recorded after 60 minutes since the return to standard mixture ventilation)
- oxygen requirements after 180 minutes of standard ventilation(recorded after 180 minutes since the return to standard mixture ventilation)
- baseline capillary blood gas analysis(blood samples drawn at baseline)
- capillary blood gas analysis after 3 hours of heliox(blood samples drawn after 3 hours of heliox ventilation)
- capillary blood gas analysis after 3 hours of standard mixture(blood samples drawn after 3 hours of standard mixture ventilation)
- baseline heart rate(measured at baseline)
- heart rate after 180 minutes of standard mixture(measured after 180 minutes since the return to standard mixture ventilation)
- baseline oxygen saturation(measured at baseline)
- oxygen saturation after 15 minutes of heliox(measured 15 minutes after heliox ventilation)
- oxygen saturation after 60 minutes of heliox(measured 60 minutes after heliox ventilation)
- oxygen saturation after 180 minutes of heliox(measured 180 minutes after heliox ventilation)
- oxygen saturation after 15 minutes of standard mixture(measured 15 minutes since the return to standard mixture ventilation)
- oxygen saturation after 60 minutes of standard mixture(measured 60 minutes since the return to standard mixture ventilation)
- oxygen saturation after 180 minutes of standard mixture(measured 180 minutes since the return to standard mixture ventilation)
研究者
Tomasz Szczapa
Deputy Head - Department of Neonatology; Head - Neonatal Biophysical Monitoring and Cardiopulmonary Therapies Research Unit
Poznan University of Medical Sciences