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临床试验/NCT04391634
NCT04391634已完成不适用

Cerebral Oxygenation and Circulatory Parameters During Pressure Controlled vs. Volume Targeted Mechanical Ventilation in the Extremely Preterm Infants With Respiratory Distress Syndrome

Poznan University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Stroke volume variation (SVV)

研究概览

简要总结

The aim of the study was to assess the effect of volume targeted vs. pressure-controlled mechanical ventilation (MV) on circulatory parameters and cerebral oxygenation in the extremely preterm infants.

详细描述

Prospective, cross-over trial enrolling neonates <28 weeks' gestation requiring MV. Patients were ventilated for 3 hours with pressure controlled assist-control (PC-AC) mode, followed by 3-hours of volume guarantee assist-control ventilation (VG-AC). Continuous monitoring was carried out using pulse oximetry (oxygen saturation - SpO2 and heart rate - HR), near-infrared spectroscopy (cerebral oxygenation - StO2) and electrical cardiometry (circulatory parameters).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
24 Weeks 至 27 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • premature infants born <28 weeks of gestation
  • respiratory failure in the course of respiratory distress syndrome requiring mechanical ventilation
  • stable condition with pH (acidity of blood)> 7.2 and pCO2 (carbon dioxide partial pressure) <60 mmHg in the blood gas analysis
  • no identified genetic syndromes and serious congenital malformations

排除标准

  • lack of written consent of patients' parents

结局指标

主要结局

Stroke volume variation (SVV)

时间窗: 6 hours

Stroke volume variation (SVV) monitored with electrical cardiometry \[percent\]

Index of contractility

时间窗: 6 hours

Index of contractility (ICON) monitored with electrical cardiometry

Stroke volume

时间窗: 6 hours

Stroke volume (SV) monitored with electrical cardiometry \[ml\]

Cardiac output

时间窗: 6 hours

Cardiac output (CO) monitored with electrical cardiometry \[L/min\]

Stroke index

时间窗: 6 hours

Stroke index (SI) monitored with electrical cardiometry \[ml/m2\]

Cardiac index

时间窗: 6 hours

Cardiac index (CI) monitored with electrical cardiometry \[L/min/m2\]

StO2

时间窗: 6 hours

Cerebral oxygenation measured using near-infrared spectroscopy \[percent\]

次要结局

未报告次要终点

研究者

发起方
Poznan University of Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (2)

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