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临床试验/NCT07133698
NCT07133698已完成不适用

High Flow Nasal Cannula vs. High Velocity Nasal Insufflation for Weaning From Mechanical Ventilation in Respiratory ICU

Assiut University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年2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
入组人数
105
试验地点
1
主要终点
Successful weaning

研究概览

简要总结

In intensive care units (ICUs), approximately 10% to 15%of patients ready to be separated from a ventilator experience extubation failure leading to reintubation. In patients considered at high risk, these rates can even exceed 20%. Because reintubation is associated with particularly high mortality a strategy of oxygenation aimed at avoiding reintubation deserves consideration. Although noninvasive ventilation may prevent postextubation respiratory failure in patients at high risk only 2 small-scale randomized clinical trials (RCTs) have shown decreased reintubation rates compared with standard oxygen. The most recent international clinical practice guidelines recommend the use of noninvasive ventilation to prevent post extubation respiratory failure in patients at high risk of extubation failure (7). However, up until now, no large-scale RCT has demonstrated a significant reduction of reintubation rates with noninvasive ventilation compared with standard oxygen. Thereby, most patients are treated with standard oxygen in clinical practice and only10% of them receive noninvasive ventilation after extubation in the ICU.

High-flow nasal cannula (HFNC) oxygen therapy is a new type of respiratory support system which can supply high flow mixed gases through special nasal prongs at a sufficient temperature and humidity for patient comfort. Many studies have confirmed that the comfort and tolerance of HFNC is significantly higher than that of NIV. As an alternative to NIV, HFNC has been shown to be as efficacious as NIV in preventing post-extubation respiratory failure or re-intubation in patients with hypoxemic respiratory failure.

High-velocity nasal insufflation, a form of high-flow nasal cannula, focuses on optimum efficiency of the dead-space purge to augment ventilation (removal of carbon dioxide from the dead space between breaths), in addition to providing other effects of high-flow nasal cannula. This is accomplished by use of small-bore nasal cannulae (typically 2.7-mm internal diameter for adult patients) to produce high velocity flow that is approximately 360% greater than that of the larger bore cannulae used in previous studies. According to flow analyses8 and clinical experience, high velocity nasal insufflation typically requires a flow of 25 to 35 L/min in adults to accomplish a complete purge of the extrathoracic anatomic reservoir between breaths.

详细描述

All patients were submitted to, History, Clinical examination, ABG, Laboratory assessment: as needed, ICU scores: APACHE II score.

Weaning from mechanical ventilation procedure:

The procedure of weaning from mechanical ventilation will be considered as early as possible. Patients who received mechanical ventilation >24 h will receive daily screening of subjective and objective indices for assessment of readiness to wean. Weaning will be conducted according to the statement of the ERS, ATS, ESICM, SCCM and SRLF.

Subjects who fulfill criteria for weaning readiness will be extubated and randomized in a ratio of 1:1:1 to either HVNI or HFNC or Noninvasive ventilation.

Weaning procedure will be considered successful when the spontaneous breathing is sustained for 48 consecutive hours without respiratory distress, with pH>7.35 and PaO2>60 mm Hg in a patient breathing through a mask at FiO2≤0.5.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (≥18 years) intubated for >24 hours due to acute respiratory failure, identified as high-risk for extubation failure AND fulfilling standard readiness-to-wean criteria (e.g., resolution of cause of intubation, adequate gas exchange [P/F ≥150], hemodynamic stability, spontaneous breathing trial [SBT] success)

排除标准

  • •Patients with central nervous system disorders unrelated to hypercapnic encephalopathy or hypoxemia.
  • •Patients with post arrest encephalopathy.
  • •Patient with previous tracheotomy.
  • •Patients who received noninvasive ventilation without subsequent intubation.
  • •Patients with end organ failure.

研究组 & 干预措施

Noninvasive ventilation weaning

Active Comparator

NIV Arm: Non-Invasive Ventilation (Mode: [e.g., PSV], IPAP: [e.g., 8-12 cmH₂O], EPAP: [e.g., 4-6 cmH₂O], FiO₂ titrated to SpO₂ ≥92%) delivered via [e.g., oronasal mask] for ≥16 hours/day initially, with weaning per protocol.

干预措施: Noninvasive ventilation (Device)

HFNC weaning

Experimental

HFNC Arm: High-Flow Nasal Cannula (Flow: 50-60 L/min, FiO₂ titrated to SpO₂ ≥92%).

干预措施: High Flow nasal Cannula (Device)

HVNI weaning

Experimental

HVNI Arm: High-Velocity Nasal Insufflation (Flow: 40-60 L/min, FiO₂ titrated to SpO₂ ≥92%).

干预措施: High velocity nasal insufflation (Device)

结局指标

主要结局

Successful weaning

时间窗: 48 hours

Weaning procedure will be considered successful when the spontaneous breathing is sustained for 48 consecutive hours without respiratory distress, with pH\>7.35 and PaO2\>60 mm Hg in a patient breathing through a mask at FiO2≤0.5

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

Waleed Gamal Elddin Khaleel

Assistant professor of chest diseases

Assiut University

研究点 (1)

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