NCT01530282Unknown2 期
Non-invasive Respiratory Mechanics Assessment During Spontaneous / Assisted Breathing: The ERNI (Elastance, Resistance, Non Invasive Measurements) Study
University of Turin, Italy0 个研究点目标入组 15 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 15
- 主要终点
- Non-invasive respiratory mechanics measurement
研究概览
简要总结
The study aims to assess the agreement between respiratory mechanics parameters measured noninvasively by means of brief airways occlusions at the beginning of inspiration and the reference parameters obtained with standard techniques of esophageal and gastric pressure under static and dynamic conditions in a mixed population of ICU patients mechanically ventilated in pressure support ventilation mode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •intact respiratory drive;
- •PaO2/FiO2 ratio > 150 with a positive end-expiratory pressure (PEEP) ≤ 8 cmH2O;
- •pH between 7.35 and 7.45;
- •patient alert, conscious, and cooperative with a Glasgow Coma Scale ≥ 10.
排除标准
- •infection, sepsis or septic shock; (with fever no)
- •hemodynamic instability;
- •respiratory centres depression;
- •esophageal deformity, or gastric/esophageal illnesses;
- •previous recent gastric/esophageal surgery.
结局指标
主要结局
Non-invasive respiratory mechanics measurement
时间窗: 2 hours
use of 150-200 ms airway occlusions at the beginning of inspiration to measure non-invasive respiratory mechanics
次要结局
未报告次要终点
研究者
Marco Ranieri
MD Professor
University of Turin, Italy
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