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临床试验/NCT01042080
NCT01042080已完成不适用

Effect of Mechanical Ventilation With NAVA and PSV on Inspiratory Muscle Workload and Synchrony in Patients With Chronic Obstructive Pulmonary Disease

Hôpital Européen Marseille4 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年12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
发起方
入组人数
16
试验地点
4
主要终点
Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)

研究概览

简要总结

NAVA used the electrical activity of the diaphragm (EAdi) to initiate and deliver in proportion of an inspiratory assistance. During inspiration, EAdi signal occurred earlier than airflow or pressure variations in the airway. The investigators hypothesized that NAVA improved patient-ventilator synchrony and reduced inspiratory workload as compared with pressure support ventilation delivered at two different cycling criteria (25 and 50 %).

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • History of chronic obstructive pulmonary disease
  • Admitted for acute respiratory failure requiring invasive mechanical ventilation
  • Currently receiving pressure support ventilation

排除标准

  • Age < 18 years
  • Respiratory rate > 35 bpm
  • Severe hypoxemia with SpO2 < 88 % and FIO2 > 50 %
  • Heart rate > 120 bpm
  • Systolic arterial pressure < 90 mmHg
  • Contraindication to naso-gastric tube's insertion

研究组 & 干预措施

PSV-ET 25

Active Comparator

Pressure support ventilation with expiratory trigger set at 25 %.

干预措施: Expiratory trigger (ET) (Other)

PSV-ET 50

Active Comparator

Pressure support ventilation with expiratory cycling set at 50 %.

干预措施: Expiratory trigger (ET) (Other)

NAVA

Experimental

NAVA level is adjusted to achieve similar peak inspiratory pressure levels than during PSV.

干预措施: NAVA (Device)

结局指标

主要结局

Inspiratory muscle workload as reflected by the diaphragmatic Pressure Time Product (PTPdi)

时间窗: 5 minutes

次要结局

  • Arterial blood gases(20 minutes)
  • Trigger delay(5 minutes)
  • Ineffective inspiratory effort(5 minutes)
  • Dynamic intrinsic PEEP(5 minutes)

研究者

发起方
Hôpital Européen Marseille
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerome Allardet-Servent, MD

MD, MSc

Hôpital Européen Marseille

研究点 (4)

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