Randomized Controlled Trial to Investigate the Effect of High Flow Nasal Cannula Treatment on Carbon Dioxide-levels in COPD- Patients With Acute Hypercapnic Respiratory Failure, Using Either OptiflowTM or Optiflow+DuetTM Nasal Cannula
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 138
- 主要终点
- Normalization of pH
研究概览
简要总结
Hypothesis Treatment with HFNC and OptiflowTM+Duet can significantly reduce PaCO2 and normalize pH in patients with COPD exacerbation and acute hypercapnic failure, compared to HFNC with OptiflowTM.
Treatment with High flow and OptiflowTM+Duet in patients with COPD exacerbation and acute hypercapnic failure is well tolerated.
Aims To investigate the effect of HFNC in combination with either OptiflowTM or OptiflowTM+Duet nasal cannula on PaCO2 levels and pH in patients with COPD exacerbation and acute hypercapnic failure and compare the results of treatment with the two different nasal cannulas.
To describe adherence to treatment with high flow and either OptiflowTM or OptiflowTM+Duet nasal cannula.
Methods Study design The study will be carried out as a prospective, multicenter, randomized controlled trial.
- Patients COPD and acute hypercapnic who do not tolerate NIV-treatment will be treated with HFNC for respiratory support. Patients will be randomized to either OptiflowTM /OptiflowTM+Duet nasal cannulas ("Fisher & Paykel Healthcare", Auckland, New Zealand)
- HFNC treatment with allocated nasal cannula, flow 40-60 (prescribed by the responsible clinician) will be initiated, titration of FiO2 till target SO2 is reached (as prescribed by the responsible clinician or by default 88-92%). Maximal flow and target saturation should be reached within 1.5 hours of initiation.
- Arterial puncture (registering pH, PaO2, PaCO2, HCO3, SaO2 and Base Excess) will be drawn at baseline and repeated after two hours (±30 minutes and after flow and FiO2 have been stable for 30 minutes) and at termination of the HFNC.
- Patients will remain in study till it is decided by the treating physician to terminate HFNC-treatment. Patients who are candidates for invasive ventilations will be excluded from the study if the arterial blood gasses further deteriorate after initiation of HFNC.
详细描述
The newly developed OptiflowTM+Duet with different sizes of the two nasal prongs and is primarily intended for use in an acute setting. Compared to the original OptiflowTM nasal cannula, the OptiflowTM +Duet is predicted to deliver a doubled to tripled airway pressure, depending on flow. Whether the OptiflowTM+Duet nasal cannula effectively can reduce PaCO2 and normalize pH in patients with COPD exacerbation and acute hypercapnic failure is unknown.
Aims To investigate the effect of HFNC in combination with either OptiflowTM or OptiflowTM+Duet nasal cannula on PaCO2 levels and pH in patients with COPD exacerbation and acute hypercapnic failure and compare the results of treatment with the two different nasal cannulas.
To describe adherence to treatment with high flow and either OptiflowTM or OptiflowTM+Duet nasal cannula.
Study design The study will be carried out as a prospective, multicenter, randomized controlled trial including patients from pulmonary wards in three Danish hospitals: Bispebjerg Hospital, Copenhagen, Viborg Hospital, Viborg, and Aalborg University Hospital, Aalborg, Denmark.
First patient in and study duration The study is initiated Jan 31. 2024. All sites will be ready to include patients from June 30, 2024.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 40 years old.
- •A diagnosis of COPD, according to GOLD recommendations1, or clinical suspicion of COPD.
- •Patients admitted with exacerbation, according to GOLD recommendations1, causing acute hypercapnic respiratory failure (pH≤7.35, pCO2 >6.0 kPa) who do not tolerate NIV treatment.
- •Exclusion criteria:
- •Patients with acute hypercapnic respiratory failure caused by other diseases than COPD exacerbation, such as, but not limited to, acute heart failure, judged by the responsible clinician.
- •Patients with combined metabolic- and respiratory acidosis (HCO3 < 21.8 mmol/l, (female), 22.5 mmol/l, (male), and/or lactate >2.5 mmol/l).
- •Patients with terminal illness
- •Patients who are incapable of giving informed consent.
排除标准
- 未提供
结局指标
主要结局
Normalization of pH
时间窗: through study completion, a maximum of one week
Number of patients with acute exacerbations of COPD including acute hypercapnic respiratory failure
Time to normalization of pH
时间窗: through study completion, a maximum of one week
Time till patients with acute exacerbations of COPD including acute hypercapnic respiratory failure normalize pH
次要结局
- Adherence to High Flow Nasal Cannula(through study completion, a maximum of one week)
研究者
Ulla Møller Weinreich
Professor
Aalborg University Hospital