A High-Flow Nasal Cannula Versus Noninvasive Ventilation in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Single-blind Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Changes in pH in arterial blood gas before vs. after treatment
研究概览
简要总结
The investigators investigated the efficacy and safety of High Flow Nasal Cannula (HFNC) at different flow rates compared to non-invasive ventilation (NIV) in patients presenting to the emergency department (ED) with acute exacerbations of Chronic obstructive pulmonary disease (COPD) who did not respond adequately to bronchodilator therapy and continued to exhibit hypercapnic respiratory failure. Specifically, the investigators tested the hypothesis that HFNC would be more effective at reducing partial pressure of carbon dioxide (PaCO2) levels and hospital stay duration and would be associated with greater patient comfort than NIV.
详细描述
The patients were divided randomly into one of three study groups: NIV, HFNC-30, and HFNC-50. The investigators collected patient data, including demographic characteristics (age and sex), vital signs upon admission (systolic blood pressure [SBP], respiratory rate [RR], and heart rate [HR]), complaints and symptoms upon admission, initial arterial blood gas parameters (e.g., pH, PaCO2, lactate, and bicarbonate), length of stay, ED revisits, patient satisfaction, intubation status, and clinical outcomes (hospitalization, admission to the intensive care unit [ICU], or 28-day mortality). Changes in arterial blood gas parameters (e.g., ΔpH, ΔPaCO2, Δlactate, and Δbicarbonate) before treatment vs. 30, 60, and 120 minutes after treatment were recorded using a pre-prepared case data form.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
In this single-blind study, we assigned the participants randomly to one of three treatment groups using a computer-generated randomization program (SAS Institute, 1990). Each participant was assigned an identification number indicating their treatment group. An experienced clinician, who was blinded to the null hypothesis and did not participate in the evaluation of results, administered the treatments and recorded patient data on a pre-prepared case data form.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- patients age ≥18 years with a confirmed diagnosis of COPD who presented to the ED with exacerbations that did not respond to bronchodilator therapy
排除标准
- •patients aged younger than 18 years
- •patients had an arterial pH ≤ 7.25;
- •patients were in cardiopulmonary arrest;
- •patients had unstable cardiac arrhythmias or hemodynamic instability;
- •patients showed persistent hypoxemia despite supplemental oxygen therapy;
- •patients were unconscious or uncooperative;
- •patients could not protect their airway or manage secretions;
- •patients had cardiogenic pulmonary edema, active hemoptysis, pneumothorax, recent upper respiratory tract/esophagus surgery, significant airway obstruction (e.g., laryngeal mass or tracheal tumor), active upper gastrointestinal bleeding, or facial trauma or deformities
结局指标
主要结局
Changes in pH in arterial blood gas before vs. after treatment
时间窗: at 30, 60, and 120 minutes relative to baseline
The investigators assessed the changes in pH before treatments vs. 30, 60, and 120 minutes after treatments.
Changes in bicarbonate in arterial blood gas before vs. after treatment
时间窗: at 30, 60, and 120 minutes relative to baseline
The investigators assessed the changes in bicarbonate before treatments vs. 30, 60, and 120 minutes after treatments.
Changes in lactate in arterial blood gas before vs. after treatment
时间窗: at 30, 60, and 120 minutes relative to baseline
The investigators assessed the changes in lactate before treatments vs. 30, 60, and 120 minutes after treatments.
Changes in PaCO2 in arterial blood gas before vs. after treatment
时间窗: at 30, 60, and 120 minutes relative to baseline
The investigators assessed the changes in PaCO2 before treatments vs. 30, 60, and 120 minutes after treatments.
次要结局
- Assessing the need for rescue treatment and treatment-related complications(120 minutes after initial treatment)
研究者
Adem Az
Principal Investigator
Haseki Training and Research Hospital