A Randomized Controlled Trial of BiPhasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) vs. Non-invasive High Frequency Ventilation (NIHFV) Following NCPAP Failure: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP
研究概览
简要总结
In preterm infants, endotracheal mechanical ventilation is well known to cause various forms of lung injury including volutrauma, barotrauma and oxytrauma - collectively known as ventilator-induced lung injury (VILI). As such, there is a move towards non-invasive ventilation (NIV) in recent decades. However, many infants placed on NIV modes fail and require intubation. A relatively recent mode of NIV is non-invasive high frequency ventilation (NIHFV). Studies on this modality are scarce, but do suggest that neonates can be ventilated effectively. However, its efficacy in comparison with other existing modes of NIV remains unknown due to lack of appropriate studies. The investigators hypothesize that NIHFV is a superior NIV mode than Biphasic Nasal Continuous Positive Airway Pressure (BP-NCPAP) in preterm infants in preventing intubation following NCPAP failure.
详细描述
Intubation and mechanical ventilation has long been the mainstay in managing infants with respiratory disease in the neonatal intensive care unit (NICU). However, in recent decades, the use of endotracheal mechanical ventilation (EMV) has been implicated as a major cause of ventilator-induced lung injury (VILI).Prolonged endotracheal intubation in the neonate has been linked with morbidities including bronchopulmonary dysplasia (BPD), nosocomial pneumonia, air leak syndromes and subglottic stenosis. Moreover, BPD has been linked with impaired neurodevelopmental outcome.
There has been a conscious effort amongst neonatologists to reduce the duration of EMV to minimize these undesirable side effects. Non-invasive ventilatory support has been increasingly used to that effect in recent years. Various forms of NIV including NCPAP, BP-NCPAP and nasal intermittent positive pressure ventilation (NIPPV) have become part of the ventilatory management of neonates in NICUs across the globe.
Originally described in the early 1970s,9 the use NCPAP has seen renewed interest since the 1990s when the significance of VILI became apparent. In retrospective studies, NCPAP has been shown to reduce the rates of bronchopulmonary dysplasia (BPD). A recent multi-center prospective randomized controlled trial of infants between 25 and 28 week gestation showed that infants treated with early NCPAP required fewer days of ventilation and had a reduced oxygen dependency after 28 days (although not at 36 weeks corrected GA). A subsequent analysis of these patients showed improved lung mechanics and gas exchange. However NCPAP use is not without its risks. Air leak syndromes, diminished cardiac output, gaseous distention and nasal injury/excoriations are well described complications of its use. Despite these drawbacks, NCPAP remains an efficacious modality to help reduce endotracheal intubation and limit VILI.
Although successful in reducing the reliance on EMV, it is also well known that up to 43-80% of neonates with moderate to severe respiratory disease treated with NCPAP fail and require intubation. BiPhasic NCPAP and NIPPV have been used with increasing frequency in NICUs in recent years to help prevent re-intubation, but with limited evidence guiding their use.
BiPhasic-NCPAP, described in the late 1980s as a form of augmented ventilation, provides two levels of non-invasive pressure support, typically cycled between 20-30 times per minute and the upper level of support usually lasting one second. As in NCPAP, the patient breathes around the two levels of pressures provided. However, there is currently no evidence to suggest that the use of BP-NCPAP offers any advantage over NCPAP. In a recent randomized controlled prospective study from the investigators centre comparing BP-NCPAP (N=69) and NCPAP (N=67), the former was not shown to be superior to the latter in facilitating sustained extubation in infants < 1,250 grams (67% vs. 58%, P = 0.27). Nevertheless, it is presumed that BP-NCPAP offers the same benefits as NCPAP, and remains in use as a rescue mode of NIV across many NICUs after NCPAP failure.
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
- None
入排标准
- 年龄范围
- 72 Hours 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Greater than 72 hours post-natal age AND currently on NCPAP
- •Less than 1,250 g when on NCPAP at time of enrollment
排除标准
- •Congenital or acquired abnormality of upper airways
- •Severe congenital anomalies including cyanotic congenital heart disease
- •Severe nasal excoriation/injury preventing use of NIV interface
- •Greater than 2,000 grams at time of randomization
研究组 & 干预措施
NIHFV
NIHFV will be provided using the Drager VN500, using either nasal prong or mask interfaces.A blood gas (arterial if an arterial line exists, or a capillary sample) will be drawn at the time of NCPAP failure (time 0) unless one was done within 1 hour preceding the randomization. The blood gas will then be repeated at 1 hour and recorded along with TcCO2 monitor data (if available). Initial settings for NIHFV arm will be MAP of 8 cm H2O, frequency of 10 Hz, and amplitude of 20 cm H2O. The maximum allowable MAP will be 10 cm of H2O. The range of frequency allowed will be 6 - 14 Hz. Both frequency and amplitude will be adjusted to try and achieve palpable/visible chest movement and to achieve target CO2 levels for the particular patient.
干预措施: NIHFV (Device)
BP-NCPAP
Nasal BP-NCPAP will be delivered using the Infant Flow® SiPAP™ and either nasal prongs or mask interface. A blood gas (arterial if an arterial line exists, or a capillary sample) will be drawn at the time of NCPAP failure (time 0) unless one was done within 1 hour preceding the randomization. The blood gas will then be repeated at 1 hour and recorded along with transcutaneous carbon dioxide (TcCO2) monitor data (if available). Initial settings of BP-NCPAP will be a lower level PEEP of 5 cm water (H2O) and a higher level PEEP of 8 cm H2O at a cycle rate of 20 per minute with 1 second at the higher PEEP per cycle. The settings can then be adjusted and titrated up to a maximum of 7 and 10 cm H2O for the lower and higher PEEPs respectively at a maximum rate of 30 cycles per second based on fraction of inspired oxygen (FiO2) requirements.
干预措施: BP-NCPAP (Device)
结局指标
主要结局
Failure of assignmed non-invasive mode post randomization to NIHFV or BP-CPAP
时间窗: 72 hours
次要结局
- Rates of intraventricular hemorrhage (IVH)(until discharge)
- Rates of BPD(until discharge)
- Intubation rates at 72 hours and 7 days post randomization(7 days)
- Comparison of the number of apneic spells(7 days)
- PaCO2 levels at time of initiation(2 hours)
- Rates of adverse outcomes between the 2 groups(2 months)
- Time to discharge from hospital(2 months)
- PaCO2 1 hour post NIV mode(1 hour)
- Time to re-intubation(7 days)
- Total number of days on Endotracheal Mechanical Ventilation(2 months)
研究者
Vibhuti Shah
Staff Neonatologist, Mount Sinai Hospital
Mount Sinai Hospital, Canada
