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Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

2020年7月21日 更新者：Christoph Czernik、Charite University, Berlin, Germany

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

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).

研究概览

地位

终止

条件

干预/治疗

详细说明

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:

Assuming a variability of the paCO2 as previously reported for difficult-to-wean preterm infants in our unit (Czernik C, J Matern Fetal Neonatal Med 2012) and a treatment failure rate of 22% within 72 hours after extubation, we calculated a sample size of 34 patients in each study arm to detect a difference in the paCO2 of 7 mmHg, using a two-sided significance of 0.05 and a power of 0.8.

Randomization:

Sequence generation by an independent statistician and a study nurse. Block randomization using at least two different block sizes. Allocation concealment using sequentially numbered opaque sealed envelopes.

Data monitoring:

By an independent statistician.

研究类型

介入性

注册 (实际的)

6

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 德国
      • Berlin、德国
        • Dpt. of Neonatology, Charité - Universitätsmedizin Berlin

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

5天 至 4周 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：nHFOV
Extubation to ventilator-derived nHFOV using binasal prongs
有源比较器：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.
设备：nCPAP
Extubation to ventilator-derived nCPAP using binasal prongs

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
paCO2 at 72 h After Extubation
大体时间：64 h to 80 h
Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.
64 h to 80 h

次要结果测量

结果测量
措施说明
大体时间
pH at 2 h After Extubation
大体时间：within the first 6 h after extubation
within the first 6 h after extubation
paO2 at 2 h After Extubation
大体时间：within the first 6 h after extubation
within the first 6 h after extubation
paCO2 at 2 h After Extubation
大体时间：within the first 6 h after extubation
within the first 6 h after extubation
Base Excess at 2 h After Extubation
大体时间：within the first 6 h after extubation
within the first 6 h after extubation
pH at 72 h After Extubation
大体时间：64-80 h after extubation
64-80 h after extubation
paO2 at 72 h After Extubation
大体时间：64-80 h after extubation
64-80 h after extubation
Base Excess at 72 h After Extubation
大体时间：64-80 h after extubation
64-80 h after extubation
Successful Extubation
大体时间：72 h after extubation
Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure"
72 h after extubation
Treatment Failure
大体时间：within 7 days after extubation
Defined as the number of patients reaching the criterion of "treatment failure"
within 7 days after extubation
Reintubation
大体时间：within 7 days after extubation
Defined as the number of patients being reintubated
within 7 days after extubation
Highly Viscous Secretions
大体时间：within 72 hours after extubation
Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient
within 72 hours after extubation
Other Adverse Effects
大体时间：until discharge
Incidences of the following adverse effects: Intraventricular hemorrhage III°-IV° (Papile), surgical necrotizing enterocolitis, pneumothorax, pulmonary interstitial emphysema, persistent ductus arteriosus requiring surgical closure, retinopathy of prematurity requiring laser treatment and/or injection of bevacizumab, death or moderate to severe bronchopulmonary dysplasia (Jobe) at 36 weeks' gestational age, periventricular leukomalacia
until discharge
Duration of Respiratory Support
大体时间：until discharge
Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen
until discharge

其他结果措施

结果测量
措施说明
大体时间
pH at 2 h After Switch to "Rescue Treatment"
大体时间：within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
paO2 at 2 h After Switch to "Rescue Treatment"
大体时间：within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
paCO2 at 2 h After Switch to "Rescue Treatment"
大体时间：within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
Base Excess at 2 h After Switch to "Rescue Treatment"
大体时间：within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
Successful Rescue
大体时间：72 h after switch to "rescue" treatment
Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure"
72 h after switch to "rescue" treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Charite University, Berlin, Germany

调查人员

  • 首席研究员：Christoph Czernik, MD PhD、Charite University, Berlin, Germany

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年1月1日

初级完成 (实际的)

2017年12月31日

研究完成 (实际的)

2017年12月31日

研究注册日期

首次提交

2015年1月10日

首先提交符合 QC 标准的

2015年1月13日

首次发布 (估计)

2015年1月16日

研究记录更新

最后更新发布 (实际的)

2020年8月5日

上次提交的符合 QC 标准的更新

2020年7月21日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • EA2/011/12

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