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临床试验/NCT05759832
NCT05759832已完成不适用

Modified Nasal High-flow Oxygen Therapy for Acute Respiratory Failure Patients Undergoing Flexible Bronchoscopy

Beijing Chao Yang Hospital4 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2023年4月1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
160
试验地点
4
主要终点
Need to increase ventilatory support

研究概览

简要总结

Acute respiratory failure (AFR) is a serious condition that requires prompt and appropriate intervention to prevent further deterioration and improve outcomes. Bronchoscopy is a commonly used diagnostic and therapeutic procedure in patients with respiratory failure. However, traditional low-flow oxygen supplementation during bronchoscopy may not provide adequate oxygenation and ventilation, leading to complications and worsening of the patient's condition.

High-flow nasal cannula therapy has improved oxygenation and ventilation in critically ill patients, making it a promising alternative to traditional oxygen supplementation during bronchoscopy. The bronchoscope is passed through the nose during all procedures in our center. HFNC oxygen therapy is applied to both nostrils. The bronchoscope occupies one of the nares receiving oxygen therapy during bronchoscopy. As a result, the application of HFNC needs to be optimized. Therefore, the investigators designed a modified HFNC with a single cannula. However, limited data exist on the safety and efficacy of modified HFNC therapy in patients with respiratory failure undergoing bronchoscopy.

Therefore, the aim of this study is to evaluate the impact of modified HFNC therapy on the outcomes of undergoing bronchoscopy in patients with ARF. The findings of this study will contribute to understanding the role of modified HFNC therapy in managing ARF and inform clinical practice.

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 (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Age ≥18 years;
  • Respiratory failure defined as a ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) <300 mm Hg;
  • Clinical indication for FB to diagnose or treat pulmonary disease.

排除标准

  • Pre-existing endotracheal intubation or tracheostomy;
  • Required immediate endotracheal intubation;
  • PaO2/FiO2 <150 mm Hg;
  • Platelet count <60 × 109/L;
  • History of myocardial infarction within the past 6 weeks;
  • Nasopharyngeal obstruction or blockage;
  • Presence of chest skin lesions contraindicating the application of electrical impedance tomography (EIT);
  • Intolerance to HFNC oxygen therapy.

结局指标

主要结局

Need to increase ventilatory support

时间窗: Within 24 hours after bronchoscopy

The primary outcome was the need for respiratory support escalation within 24 hours after FB. Escalation was defined as meeting any of the following criteria: 1. Escalation to invasive mechanical ventilation (IMV); 2. Escalation to non-invasive ventilation (NIV); 3. Escalation to HFNC oxygen therapy; 4. An increase in support parameters without changing the level of respiratory support: For NIV patients: a \>20% increase in inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), or fraction of inspired oxygen (FiO2); For HFNO patients: a \>20% increase in flow rate or FiO2; For low-flow nasal oxygen (LFNO) therapy patients: a \>50% increase in oxygen flow rate.

Need to increase ventilatory support

时间窗: Within 24 hours after bronchoscopy

The primary outcome was the need for respiratory support escalation within 24 hours after FB. Escalation was defined as meeting any of the following criteria: 1. Escalation to invasive mechanical ventilation (IMV); 2. Escalation to non-invasive ventilation (NIV); 3. Escalation to HFNC oxygen therapy; 4. An increase in support parameters without changing the level of respiratory support: For NIV patients: a \>20% increase in inspiratory positive airway pressure (IPAP), expiratory positive airway pressure (EPAP), or fraction of inspired oxygen (FiO2); For HFNO patients: a \>20% increase in flow rate or FiO2; For low-flow nasal oxygen (LFNO) therapy patients: a \>50% increase in oxygen flow rate.

次要结局

  • A hierarchy of escalated respiratory support forms based on clinical severity(Within 24 hours after bronchoscopy)

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rui Wang

Attending doctors

Beijing Chao Yang Hospital

研究点 (4)

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