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临床试验/NCT02571231
NCT02571231Unknown不适用

Pilot Study: High Flow Ventilation With Volume Guarantee

Oslo University Hospital0 个研究点目标入组 15 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
15
主要终点
stability of High Frequency Tidal volumes

研究概览

简要总结

The trial is a pilot study performed in the NICU's at Oslo University Hospital and Haukeland University Hospital preparing a multi-center randomized, controlled unblinded cross-over study, comparing high frequency ventilation (HFV) with and without volume guarantee (VG).

详细描述

HFV is a way to deliver mechanical breathing support to patients with respiratory failure applied in Neonatal Intensive Care Units (NICU's). In some NICU's, this mode of ventilation is applied when conventional ventilation fails, whereas in other units HFV is used as the primary ventilation mode.

HFV is a ventilator mode where high frequency pressure changes, typically 6-12 per second (6 - 12 Hertz (Hz)), is used to exchange air between the lungs (alveoli) and the ventilator tubing.

Concerns have been raised regarding fluctuating PCO2 values in babies receiving HFV. It is believed that stable normocapnia (normal PCO2 values) as opposed to hyper- and hypocapnia is associated to better short and long-term outcomes.

In conventional ventilator modes, CO2 diffusion is a function of the product from volume per breath (Vt) and the frequency (f) of breathing (Vt*f = minute volume (MV)). In HFV the CO2 diffusion is a function of a product from the small tidal volumes generated (Vthf) squared, and the oscillation frequency (Hz) delivered by the ventilator (vthf2 * F=DCO2). The small tidal volumes are being adjusted by altering the pressure range (amplitude) and the frequency by which pressure changes is generated. One challenge in using HFV has been unwanted fluctuations in PCO2 values, which has been shown to be associated with clinical important complications, in particular cerebral hemorrhages. In order to avoid substantial fluctuation in PCO2 a meticulous adjustment of the amplitude is required.

Modern neonatal ventilators now offer the ability to automatically adjust the amplitude of the high frequency breaths to obtain a stable high frequency tidal volume. The ventilator measures the Vthf and increase or decrease the power of each breath to obtain the set Vthf. This mode is called high frequency ventilation with volume guarantee (HFV+VG).

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
— 至 3 Months(Child)
性别
All
接受健康志愿者
否

入选标准

  • •all neonates in need of high frequency ventilator

排除标准

  • •neonates expected to need high frequency ventilator less than 48 hours because of planned surgery etc

研究组 & 干预措施

HFV+vg

Experimental

volume guarantee given

干预措施: HFV + and - VG (Device)

HFV-VG

Experimental

Volume guarantee not given

干预措施: HFV + and - VG (Device)

结局指标

主要结局

stability of High Frequency Tidal volumes

时间窗: during study, ie. 48 hours.

HFVVt are measured by ventilator.

Stability of CO2 measurements

时间窗: during study, ie. 48 hours.

Measured CO2 values will be measured as usual

frequency of needed manual adjustments on the ventilator

时间窗: during study, ie 48 hours

Adjustments made on ventilator will be automatically sampled by the ventilator

次要结局

未报告次要终点

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Sponsor

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