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临床试验/NCT05698641
NCT05698641已完成不适用

Evaluation of Efficiency of High Flow Nasal Cannula Versus Noninvasive Ventilation in Patients With Acute Hypercapnic Respiratory Failure

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
failure of treatment modality

研究概览

简要总结

Background: In acute hypoxic respiratory failure, high-flow nasal cannula (HFNC) oxygen treatment is gaining popularity. However, there is just a small body of research to back up the use of HFNC in acute respiratory failure (ARF) with hypercapnia.

Aim of study: To evaluate the effectiveness of high-flow nasal cannula (HFNC) in reducing the rate of endotracheal intubation and PCO2 level in adult patients with Acute moderate type II respiratory failure in comparison to noninvasive positive pressure ventilation (NIPPV).

Methods : A randomized control trial that was conducted on patients with acute moderate hypercapnic respiratory failure ARF (arterial blood gases pH 7.25-7.35, PaCO2>45 mmHg) who were admitted to respiratory and medical critical care units from September 2020 through February 2022 and received HFNC or NIV .The endpoint was treatment failure, which was indicated by either invasive ventilation or mortality .

详细描述

Adult patients of both sex who were admitted to ICU with acute moderate hypercapnic respiratory failure.

Included patients were divided into two groups:

  • Group A: 50 patients with acute moderate hypercapnic respiratory failure who were treated with HFNC as ventilatory support .
  • Group B: 50 patients with acute moderate hypercapnic respiratory failure who were treated with NIV as ventilatory support .

Device used:

  • For group A (HFNC) : we used either Airvo 2 Manufacturer: Fisher &Paykel Co. , Precision flow Hi - VNI ™ (Vapotherm ) or built in HFNC mode in (e Volution ventilator ) .
  • For group B (NIV) :we used Puritan Bennett™ 840 Ventilator and the used interface was oro nasal mask of fitting size to each patient .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Acute moderate Hypercapnic respiratory failure patients defined by PH: >7.25 and <7.35 and PCO2 >45mmHg who were admitted to icu and received HFNC or NIV

排除标准

  • Patients aged <18 years
  • Patients with altered consciousness defined by a Glasgow coma score of >12 points.
  • Hemodynamic instability defined by systolic arterial blood pressure 90 mmHg, mean arterial blood pressure 65 mm Hg, on vasopressor, confusion , chest pain or loss of consciousness )
  • Patients who need immediate endotracheal intubation.
  • Contraindication to NIV (oral and facial trauma, excessive phlegm with poor expectoration ability, vomiting and Epistaxis)
  • Post cardiac arrest patients.

结局指标

主要结局

failure of treatment modality

时间窗: 1 hour

failure of improvement of PH

次要结局

  • mortality(28 day)
  • ICU stay(28 day)

研究者

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

Gehad Ahmed Ali

principle investigator

Beni-Suef University

研究点 (1)

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