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临床试验/NCT04131660
NCT04131660
终止
不适用

Efficacy of Volume Targeted Pressure Support Ventilation vs. Pressure Support Ventilation in Patients With Acute Respiratory Failure at Risk of Obstructive Apneas or Obesity Hypoventilation

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 14 人2019年12月4日

概览

阶段
不适用
干预措施
AVAPS-AE mode during NIV
疾病 / 适应症
Acute Respiratory Failure
发起方
University Hospital, Rouen
入组人数
14
试验地点
1
主要终点
Resolution of hypercapnia
状态
终止
最后更新
17天前

概览

简要总结

This study compares a volume targeted pressure support non-invasive ventilation with an automatic PEP regulation (AVAPS-AE mode) to a pressure support non-invasive ventilation (S/T mode) in patients with acute hypercapnic respiratory failure with acidosis. This study focuses on patients at risk of obstructive apneas or obesity-hypoventilation syndrom (BMI≥30 kg/m²). Half of participants (33 patients) will receive non invasive ventilation with AVAPS-AE mode, the other half will receive non-invasive ventilation with S/T mode.

详细描述

So far, in respiratory intensive care units, the usual treatment of patients with acute hypercapnic respiratory failure with acidosis is non-invasive ventilation set with a pressure support mode (S/T or VS/AI mode depending on the ventilator manufacturer). AVAPS-AE mode is a volume targeted pressure support mode with an automatic PEP. With the forced oscillations method, the ventilator is able to detect the obstruction and the resistances of upper airways. It allows the ventilator to change its pressure settings to keep the targeted volume and avoid apneas and hypoventilation. That is why in patients with a BMI \> 30 kg/m², at risk of obesity hypoventilation syndrom or obstructive apneas, this ventilation mode may be interesting. AVAPS-AE has been evaluated in the home ventilation showing it is as efficient as S/T mode in controlling PaCO2. However it has never been compared to S/T mode in acute respiratory failure care.

注册库
clinicaltrials.gov
开始日期
2019年12月4日
结束日期
2021年6月30日
最后更新
17天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

发起方
University Hospital, Rouen
责任方
Sponsor

入排标准

入选标准

  • Patient of age
  • Patient benefitting of social security
  • Informed patient who signed the information note and the research enlighted consent form
  • Admission in respiratory intensive care unit for an acid-hypercapnic exacerbation (defined by pH≤ 7,35)
  • BMI ≥ 30kg/m2
  • PaCO2 \> 6.5 kPa on blood gases at ICU admission

排除标准

  • Confirmed COPD with a spirometry (VEMS/CVF \< 70%)
  • Pregnant women, or breast-feeding women
  • Patient with a judiciary or administrative liberty deprivation
  • Patients under guardianship
  • Contraindication to NIV

研究组 & 干预措施

AVAPS-AE mode

A volume targeted pressure support ventilation mode

干预措施: AVAPS-AE mode during NIV

S/T mode

A pressure support ventilation mode

干预措施: S/T mode during NIV

结局指标

主要结局

Resolution of hypercapnia

时间窗: through study completion, an average of 1 year

Time between admission and resolution of hypercapnia (≤ 6.5 kPa)

次要结局

  • Comparison of persistent apneic events on NIV (/h) during the first night(through study completion, an average of 1 year)
  • Comparison of time during NIV with a oxygen saturation below 90%(through study completion, an average of 1 year)
  • Comparison of NIV confort(through study completion, an average of 1 year)
  • Comparison of patient-ventilator asynchronisms during NIV (/h)(through study completion, an average of 1 year)
  • Comparison of length of stay(through study completion, an average of 1 year)

研究点 (1)

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