跳至主要内容
临床试验/NCT04362787
NCT04362787Unknown不适用

High Pressure Non Invasive Ventilation in Hypercapnic Respiratory Failure

Assiut University0 个研究点目标入组 52 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
52
主要终点
High pressure non invasive ventilation in acute hypercapnic respiratory failure

研究概览

简要总结

High pressure NIV is a pressure limited ventilation, stating IPAP pressure at 20 cmH2O and gradually increasing pressure up to 30 cmH2O according to patient tolerance.

详细描述

Noninvasive ventilation (NIV): refers to the administration of ventilatory support without using an invasive artificial airway (endotracheal tube or tracheostomy tube). NPPV is well established in the management of acute on chronic hypercapnic respiratory failure secondary to acute exacerbation of COPD (AECOPD), obesity hypoventilation syndrome, and restrictive thoracic disorders.

During the past years NIV was applied by using low pressure inspiratory positive airway pressure (IPAP), which means titrating inspiratory pressure starting at 10 cmH2O and increasing pressure gradually according to patient tolerance maximum up to 20 cm H2O.

There is still about 15% failure rate while using conventional low pressure NIV, this failure rate may be attributed to the following:

  1. Still in a number of patients with conventional low pressure NIV, PaCO2, and pH worsen with subsequent deterioration and need for invasive ventilation.
  2. Despite lowering PaCO2 value with conventional NIV ventilation but it is not normalized so with minimal derangement in clinical condition of the patient it worsens again.
  3. Also abnormally high level PaCO2 may have a negative impact on vital organs.
  4. Low pressure may be associated with patient intolerance , and discontinuation of NIV.

Recently high pressure NIV used aiming to improve outcome of NIV. High pressure NIV is a pressure limited ventilation, stating IPAP pressure at 20 cmH2O and gradually increasing pressure up to 30 cmH2O according to patient tolerance. High pressure NIV is expected to improve alveolar ventilation, decreasing dead space ventilation, and work of breathing, so it can improve the outcome result .

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients admitted in Assiut University Hospital and Assiut Police Hospital with acute hypercapnic respiratory failure due to COPD and Obesity hypoventilation syndrome (OHS) indicated for conventional NIV.
  • •Patients who failed on low pressure NIV will be shifted to high pressure NIV with any of these conditions:
  • •PH <7.30 or less than admission level.
  • •RR > 35b/m or more than admission level.
  • •SpO2 < 88%.
  • •Exclusion criteria: (4)
  • •Age <18 years.
  • •Excessive amount of respiratory secretions or weak cough.
  • •Upper airway obstruction.
  • •Recent oral, facial or cranial trauma or surgery.
  • •Sever abdominal distension.
  • •Active upper gastrointestinal bleeding.
  • •Cardiac or respiratory arrest.
  • •Arterial oxygen tension /fraction of inspired oxygen (PaO2 / FiO2) <150mmHg.

排除标准

  • 未提供

结局指标

主要结局

High pressure non invasive ventilation in acute hypercapnic respiratory failure

时间窗: Patients will assessed after 2 hours from increasing pressure

Effect of high pressure NIV on length of hospital stay , need for invasive mechanical ventilation, mortality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Eissa Helmy Abdelhafeez

Assistant Lecturer

Assiut University

相似试验