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临床试验/NCT04323397
NCT04323397已完成不适用

Nasal High Frequency Oscillatory Versus Synchronized Intermittent Positive Pressure Ventilation in Neonate Following Extubation: Randomized Controlled Crossover Study

Prince of Songkla University1 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2020年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
133
试验地点
1
主要终点
Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study

研究概览

简要总结

Mechanical ventilation was introduced to treat respiratory failure in preterm infants or sick neonates then improvements in survival (1,2). However, the complications from short or long term use of ventilation can result in unintended harm or burden (e.g., air leak syndrome, pneumonia, bronchopulmonary dysplasia, neurological injury, retinopathy of prematurity) (3,4). To reduce these risks, clinicians should aggressive extubated neonates as early as possible. Respiratory (focus on blood gas as well as partial pressure CO2 [pCO2]) or extubation (focus on clinical condition as well as reintubation) failure was worrisome in pediatrician and parents if the neonate was reintubated owing to complete recovery of lung disease or inadequate respiratory drive.

Non-invasive ventilation (NIV) was supported for primary respiratory support (initial mode before endotracheal intubation) or post-extubation. Nasal continuous positive airway pressure (nCPAP) was familiar to NIV mode in neonatal respiratory support. Nowadays, the new NIV modalities are nasal intermittent synchronized positive pressure ventilation (nSIPPV) and nasal high frequency oscillation (nHFO). To increase the likelihood of nCPAP success, other new modalities of NIV may be interesting. From theory, nSIPPV and nHFO combines peak inspiratory pressure (PIP) with synchrony and high-frequency oscillations without synchrony above CPAP, respectively. From meta-analysis, nSIPPV and nHFO were statistically significant superior than nCPAP both respiratory and extubation failure in neonate (5,6).

The aim of our study was to investigate the efficacy of nHFOV and nSIPPV for CO2 clearance and reintubation rate after extubated neonates. The investigators hypothesized that nHFOV mode would improve CO2 clearance better than nSIPPV mode.

详细描述

The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
1 Day 至 1 Month(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Born in hospital and admit in NICU
  • •The first endotracheal intubation and need NIV if extubation
  • •Umbilical arterial catheterization to draw the blood gas
  • •Neonate has not been intervened from another RCT study

排除标准

  • •Major congenital anomalies or chromosomal abnormalities
  • •Neuromuscular diseases
  • •Upper respiratory tract abnormalities
  • •Suspected congenital lung diseases or pulmonary hypoplasia
  • •Need for surgery known before the first extubation
  • •Grade IV intraventricular hemorrhage occurring before the first extubation
  • •Palliative care
  • •Parents' decision not to participate

研究组 & 干预措施

nasal high frequency oscillatory ventilation

Experimental

nHFO: flow 8-10 L/minute, frequency 10 Hz, MAP = "MAP (before extubation) + 2" or "8 (preterm), 10 (term)" cmH2O, dP = "2-3 times of MAP with visible chest oscillations" or 25-35 cmH2O, I:E = 1:1, FiO2 = "FiO2 (before extubation) + 0.1-0.2" keep targeted SpO2 90-94%

干预措施: Non-invasive ventilation (Device)

nasal synchronized intermittent positive pressure ventilation

Experimental

nSIPPV: flow 8-10 L/minute, rate 60/minute, PIP = "PIP (before extubation) + 2-5" or "20 (preterm), 25 (term)" cmH2O, PEEP = 5 cmH2O, IT = 0.5 s, FiO2 = "FiO2 (before extubation) + 0.1-0.2" keep targeted SpO2 90-94%. The highest trigger sensitivity avoiding auto triggering was selected.

干预措施: Non-invasive ventilation (Device)

结局指标

主要结局

Partial Pressure CO2 (pCO2) : Data From the Crossover Phase of the Study

时间窗: 2 hours after each intervention

Data from the Crossover Phase of the study: After randomization only in neonate with arterial line, the initial non-invasive ventilation (NIV) was started then blood gas was obtained after 2 hours. The participant was switched to another NIV and blood gas was obtained after 2 hours.

次要结局

  • Number of Participants With Extubation Failure: Data From the Parallel Phase of the Study.(up to 7 days after each intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anucha Thatrimontrichai

Principal Investigator

Prince of Songkla University

研究点 (1)

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