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临床试验/NCT04091269
NCT04091269已完成不适用

Automatic Adjustmen of Inspiratory Triger and Cycling-off Based on Waveform Improved Patient-ventilator Interation During Pressure Support Ventilation

Southeast University, China1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年9月18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
24
试验地点
1
主要终点
Asynchrony Index

研究概览

简要总结

Pressure Support Ventilation use Expiratory triggering sensitivity (Esense) to transfer inspiration to expiration, the value of Esense is fixed. That may lead to asynchrony between humans and ventilators, making people uncomfortable and prolonging weaning time. Furthermore,trigger delay or inffective trigger happens frequently during insppiratory triggering. The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0. It will make the transforming more synchrony with humans. The objectibe of the present study is to detect the effect of automatic adjustmen of inspiratory triger and cycling-off based on waveform on patient-ventilator interation.

详细描述

This is a physiological cross-over study. Enrolled patient with different baseline respiratory mechanics, for example ARDS patients with low compliance, COPD patient with high airway resistance and postoperative patients with almost normal compliance and airway resistance. Patients are ventilated with PSV+ Automatic adjustmen of inspiratory triger and cycling-off based on waveform, PSV with fixed inspiratory and expiratory and NAVA in two different levels of support. The demographic characteristics, diagnosis, formerly medical history, Ventilator indications, Ventilator data, other respiratory treatments, patient-ventilator interation, work of breathing, Eadi, will be recorded.

研究设计

研究类型
Interventional
分配方式
Non 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 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Postoperation patients
  • receiving invasive mechanical ventilation due to operation
  • abdominal surgery, orthopedic surgery or gynecological surgery
  • without respiratory system Comorbidity
  • able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.
  • COPD and ARDS patients
  • receiving invasive mechanical ventilation due to acute respiratory failure
  • able to sustain PSV more than 1 h with inspiratory support ≤ 15 cmH2O.

排除标准

  • age < 18 or >85 years,
  • tracheostomy at time of inclusion,
  • contra-indication for nasogastric tube insertion (e.g. history of esophageal varices, gastro-esophageal surgery in the previous 12 months or gastro-esophageal bleeding in the previous 7 days, INR ratio > 1.5 , APTT > 44 s, history of leukemia),
  • neuromuscular disease affecting spontaneous breathing (e.g. history of acute central or peripheral nervous system disorder or neuromuscular disease with irregular spontaneous rhythm),
  • hemodynamic unstable (heart rate > 140 beats/min, vasopressors required with ≥ 5 μg.kg-1.min-1 dopamine/ dobutamine, or ≥ 0.2 μg.kg-1.min-1 norepinephrine),
  • sedation level Richmond Agitation-Sedation Scale (RASS) ≤ -2 or ≥ 2,
  • lack of informed consent and patients included in other intervention study.

结局指标

主要结局

Asynchrony Index

时间窗: 20 minutes

number of asynchrony events divided by the total neural respiratory rate

次要结局

  • Patient Respiratory Patterns(20 minutes)
  • work of breathing(20 minutes)
  • other patient-ventilator synchrony parameters(20minutes)
  • gas exchange(20 minutes)

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

Principal Investigator

Southeast University, China

研究点 (1)

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