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临床试验/NCT03306524
NCT03306524已完成不适用

Investigating the Effect of Altering the Slope of the Rise in Pressure During Mechanical Ventilation of Preterm Babies

Cambridge University Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2017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
12
试验地点
2
主要终点
End tidal CO2 measurement

研究概览

简要总结

During neonatal mechanical ventilation inflating pressures, tidal volumes, and inflation and expiration times need to be set and adjusted to optimise oxygenation and carbon dioxide removal. The flow of gas into the ventilator circuit has a big effect on ventilation but is usually set to a constant value (~8 L/min) for all babies regardless of size or severity of illness, based on minimal research. High circuit flow may lead to lung damage and low flow to inadequate ventilation. The investigators recently developed a unique system to capture, record, analyse, and display ventilator data at high resolution over long periods. Using this the investigators will investigate, in within patient cross-over studies, how the level of gas flow affects ventilator parameters and ventilation, in two commonly used ventilation modes. The results will determine the lowest circuit flow that ventilates a baby safely and effectively. It will also provide preliminary data for a randomised trial.

详细描述

  • Background of the project

About 1.5% of newborns require mechanical ventilation. Although mechanical ventilation can be life-saving for neonates with respiratory failure, it may cause lung injury due to excess airway pressure (barotrauma), delivery of high tidal volumes (volutrauma) and repetitive closing/re-opening of lung units (atelectotrauma)1. Very preterm neonates are especially vulnerable to ventilator induced lung injury. Ventilator associated lung injury is one of several factors contributing to the burden of chronic lung disease of infancy, also called bronchopulmonary dysplasia (BPD).

Ventilators have several different modes. The most frequently used mode is, time-cycled, pressure limited, where the doctor sets inspired oxygen level, the peak inflation pressure (PIP), rate, and inflation time of the ventilator. In this mode the inflations are usually synchronised with the baby's breathing. This is either Synchronised Intermittent Positive Pressure Ventilation (SIPPV), where the ventilator synchronises inflations with all the baby's breaths, or Synchronised Intermittent Mandatory Ventilation (SIMV), where the ventilator only synchronises with a set number of breaths. These can be delivered with or without targeting the tidal volume delivered to a set value by adjusting the peak inflating pressure. This mode is called volume guarantee (VG). A similar mode of ventilation is flow-cycled or Pressure Support Ventilation (PSV) and can be combined with tidal volume targeting 2. In this mode the inflation is terminated as soon as the flow rate falls to 15% of the maximum flow during inflation.

These modes have continuous gas flow through the ventilation circuit. Inflation starts and pressure rises when the expiratory valve is closed. The rate of circuit flow alters the ventilation waveforms. With time-cycled ventilation the higher the circuit flow the faster the pressure rises, the lung is distended and potentially injured, and the earlier the set PIP is achieved. A high flow, with a relatively long inflation time will result in a "pressure plateau", that is the PIP is sustained after the flow, into the baby, has stopped because the lung volume is maximal at the PIP used (Figure 1). In PSV inflation stops when the flow has decreased to ~15% of the peak inflation flow and so the inflation time is shorter. Increasing the device flow shortens the inflation time and thereby reduces the mean airway pressure.

Despite the effects on ventilation patterns and the speed of lung distension and injury, consideration has rarely been given to the circuit flow. By protocol, it is usually set at 7-10 L/min when the ventilator is turned on and it is not changed.

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
Single (Participant)

盲法说明

Neonates

入排标准

年龄范围
1 Day 至 2 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Birth weight < 2 kg;
  • Ventilated with SIPPV-VG modes,
  • Informed parental consent,
  • Clinician assent.

排除标准

  • Baby's respiratory condition unstable (Inspired oxygen (FiO2) > 50%, PaCO2 > 8.5kPa or <5kPa in the last 12 hours)
  • Extubation planned in the next 12 hours;
  • Neonatal or surgical procedure in the last 12 hours or planned in the next 12 hours;
  • Significant pneumothorax requiring drainage;
  • Gas leak around the endotracheal tube >50%; #
  • No arterial access;
  • The responsible clinician does not agree with recruitment;
  • Parents do not consent.

研究组 & 干预措施

PSV_VG_0_08

Experimental

PSV VG ventilation for 15 minutes slope time = 0.08 seconds maximum inspiratory time = 0.60 seconds

干预措施: PSV_VG_0_08 (Device)

SIPPV_VG_0_16

Experimental

SIPPV VG ventilation for 15 minutes slope time = 0.16 seconds inspiratory time = 0.40 seconds

干预措施: SIPPV_VG_0_16 (Device)

SIPPV_VG_0_08

Experimental

SIPPV VG ventilation for 15 minutes slope time = 0.08 seconds inspiratory time = 0.40 seconds

干预措施: SIPPV_VG_0_08 (Device)

PSV_VG_0_16

Experimental

PSV VG ventilation for 15 minutes slope time = 0.16 seconds maximum inspiratory time = 0.60 seconds

干预措施: PSV_VG_0_16 (Device)

SIPPV_VG_0_24

Experimental

SIPPV VG ventilation for 15 minutes slope time = 0.24 seconds inspiratory time = 0.40 seconds

干预措施: SIPPV_VG_0_24 (Device)

PSV_VG_0_24

Experimental

PSV VG ventilation for 15 minutes slope time = 0.24 seconds maximum inspiratory time = 0.60 seconds

干预措施: PSV_VG_0_24 (Device)

SIPPV_VG_0_32

Experimental

SIPPV VG ventilation for 15 minutes slope time = 0.32 seconds inspiratory time = 0.40 seconds

干预措施: SIPPV_VG_0_32 (Device)

PSV_VG_0_32

Experimental

PSV VG ventilation for 15 minutes slope time = 0.32 seconds maximum inspiratory time = 0.60 seconds

干预措施: PSV_VG_0_32 (Device)

SIPPV_VG_0_40

Experimental

SIPPV VG ventilation for 15 minutes slope time = 0.32 seconds inspiratory time = 0.40 seconds

干预措施: SIPPV_VG_0_40 (Device)

PSV_VG_0_40

Experimental

PSV VG ventilation for 15 minutes slope time = 0.40 seconds maximum inspiratory time = 0.60 seconds

干预措施: PSV_VG_0_40 (Device)

结局指标

主要结局

End tidal CO2 measurement

时间窗: One year

Primary outcome will be the difference in end-tidal CO2 concentration during the epochs with slope times of 0.40 and 0.08 sec.

次要结局

未报告次要终点

研究者

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

Gusztav Belteki

Consultant Neonatologist

Cambridge University Hospitals NHS Foundation Trust

研究点 (2)

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