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临床试验/NCT02114567
NCT02114567已完成不适用

Neural Triggering and Cycling-off of Pressure Support Ventilation Improves Synchrony and Reduces Inspiratory Effort in Chronic Obstructive Pulmonary Disease.

Southeast University, China1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2014年1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
12
试验地点
1
主要终点
trigger work of breathing

研究概览

简要总结

Acute exacerbation of chronic obstructive pulmonary disease patients with intrinsic positive end-expiratory pressure (PEEPi), Neurally adjusted ventilatory assist (NAVA) reduce work of breathing and trigger delay at any external positive end-expiratory pressure (PEEPe) level compared with pressure-support ventilation (PSV)

详细描述

All patients randomly underwent a 30 mins PSV and NAVA crossover ventilation (15 mins each) at progressive PEEPe levels. Progressive levels of PEEPe were applied stepwise in increments of 40% of baseline static PEEPi, every 30 mins, from zero to 160% of baseline static PEEPi during the protocol (0, 40%, 80%, 120% and 160% of static PEEPi, respectively). During PSV, pressure support level was set to meet a Vt 6ml/kg, I/E cycling was 30% of the maximum inspiratory peak flow, flow trigger was 1L/min, and inspired fraction of oxygen (FiO2) was set to the similar level before the study protocol. During NAVA, NAVA Level was set at 15 cmH2O / µV and a peak airway pressure limit was set in order to apply the same inspiratory pressure support at each PEEPe level during PSV. The new setting of NAVA was defined as NAVA15. Moreover the trigger was set at 0.5 µV and the I/E cycling fixed at 70% of the peak of EAdi. During the entire protocol, FiO2 and peak air way pressure were maintained the same levels at each PEEPe level between PSV and NAVA. Arterial blood gases were measured at the end of PSV or NAVA15 ventilation at each PEEPe level.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •mechanical ventilation AECOPD patients with Static PEEPi measured by End-expiratory airway occlusion method ≥ of 5 cm H2O
  • •Hemodynamics stability (heart rate < 140 beats/min, no vasopressors required, or <5 μg/kg/min dopamine) without any evidence
  • •no sedation or on minimal sedation with low dose of morphine (<3mg/h, by continuous intravenous infusion
  • •Breathing spontaneously
  • •Awake and with positive cooperate

排除标准

  • •tracheostomy
  • •treatment abandonment
  • •history of esophageal varices
  • •gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 30 days
  • •coagulation disorders (INR ratio>1.5 and Activated partial thromboplastin time > 44 s)
  • •history of acute central or peripheral nervous system disorder or severe neuromuscular disease

研究组 & 干预措施

PSV ventilation

Experimental

AECOPD Patients who were ventilated wiht PSV, PEEP was titrated and set at 0, 40%, 80% and 120% PEEPi. Pressure support was set to get the tidal volume of 6ml/kg.

干预措施: PEEP titration (Other)

NAVA ventilation

Experimental

AECOPD patients who were ventilated with NAVA, PEEP was titrated and set at 0, 40%, 80% and 120% PEEPi. NAVA level was set to get the tidal volume of 6ml/kg.

干预措施: PEEP titration (Other)

结局指标

主要结局

trigger work of breathing

时间窗: 1 day

次要结局

  • patient-ventilator synchrony(1 day)

研究者

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ling Liu

Dr.

Southeast University, China

研究点 (1)

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