Nasal High Frequency Oscillation Ventilation Versus Nasal Continuous Positive Airway Pressure to Reduce Post-extubation pCO2 in Very Low Birth Weight Infants: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- paCO2 at 72 h After Extubation
研究概览
简要总结
To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low birth weight infants (VLBWs).
详细描述
Randomized controlled clinical trial comparing nHFOV vs nCPAP immediately after extubation of VLBW infants.
Intervention and treatment protocol as described for the two study arms.
Definition of treatment failure (infant meets at least one criterion):
- Sustained pCO2 >80 mmHg and pH <7.20 confirmed by arterial or capillary blood gas analysis in spite of optimized non-invasive respiratory support with maximum settings as defined above.
- Fraction of inspired oxygen (FiO2) >0.6 to maintain peripheral oxygen saturation as measured by pulse oximetry (SpO2) at 90-94% in spite of optimized non-invasive respiratory support with maximum settings as defined above.
- Reintubation (study patients may be intubated at any time, due to clinical considerations, with or without reaching another criterion of "treatment failure").
Sample size:
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
- 5 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <32+0 weeks
- •Birth weight <1500 g
- •Received mechanical ventilation via an endotracheal tube for ≥120 h
- •Caffeine treatment according to unit guidelines
- •paCO2 <65 mmHg with pH >7.2
- •FiO2 25-40% to maintain SpO2 at 90-94%.
- •Time-cycled, pressure-controlled ventilation: PIP ≤22 cm H2O, PEEP ≤6 cm H2O; Volume guarantee ventilation: Working Ppeak ≤22 cm H2O, PEEP ≤6 cm H2O; High frequency oscillation ventilation: Pmean ≤12 cm H2O, Amplitude ≤30 cm H2O
- •Decision of the attending clinician to extubate
排除标准
- •Major congenital malformation requiring surgery
- •Duct-dependent congenital heart disease
- •Neuromuscular disease
- •Participation in another randomized controlled trial
- •Death before reaching the eligibility criteria
- •Hydrocortisone treatment at the time of enrolment
- •Chronological age >28 days
研究组 & 干预措施
nHFOV
Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.
The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O.
For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician.
干预措施: nHFOV (Device)
nCPAP
Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%.
The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min.
For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician.
干预措施: nCPAP (Device)
结局指标
主要结局
paCO2 at 72 h After Extubation
时间窗: 64 h to 80 h
Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.
次要结局
- paCO2 at 2 h After Extubation(within the first 6 h after extubation)
- Base Excess at 2 h After Extubation(within the first 6 h after extubation)
- Other Adverse Effects(until discharge)
- Duration of Respiratory Support(until discharge)
- pH at 2 h After Extubation(within the first 6 h after extubation)
- pH at 72 h After Extubation(64-80 h after extubation)
- Treatment Failure(within 7 days after extubation)
- Base Excess at 72 h After Extubation(64-80 h after extubation)
- Highly Viscous Secretions(within 72 hours after extubation)
- paO2 at 2 h After Extubation(within the first 6 h after extubation)
- paO2 at 72 h After Extubation(64-80 h after extubation)
- Successful Extubation(72 h after extubation)
- Reintubation(within 7 days after extubation)
研究者
Christoph Czernik
MD
Charite University, Berlin, Germany