Supplemental Oxygen in Pulmonary Embolism (SO-PE)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pulmonary artery systolic pressure (PASP)
研究概览
简要总结
A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE).
Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.
详细描述
In the Emergency Department (ED), investigators will perform a randomized, crossover trial of adult patients with acute PE.
Study subjects will be randomized to one of two interventions (supplemental oxygen delivered by facemask) vs. room air. Therapy will be alternated at t=30, t=60, t=90 minutes, and then maintained for 180 minutes.
After each treatment change, and at 180 minutes, investigators will: 1) perform echocardiograms to determine how oxygen affects right ventricular dysfunction (RVD) and, 2) draw blood for metabolomic analyses to determine the metabolic pathways that change in response to oxygen therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
Patient
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
- •Adults ≥18 years old
- •Confirmed Pulmonary Embolism (PE) on imaging <24 hours prior to enrollment
- •New symptom onset and / or worsening symptoms <72 hours
- •Confirmation of right ventricular dysfunction (RVD) by clinician
- •Oxygen saturation ≥90% while breathing room air
排除标准
- •Hemodynamic instability
- •Use of vasopressors or mechanical circulatory support
- •Planned use of thrombolytics or plan for embolectomy
- •Oxygen saturation <90% while breathing room air
- •New onset arrhythmia
- •History of pulmonary hypertension, severe chronic obstructive pulmonary disease (COPD) requiring home oxygen or chronic steroid use, hypoventilation syndrome requiring continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP), or congestive heart failure (CHF) with LV ejection fraction < 40% or chronic oxygen therapy
- •Known pregnancy
- •Vasodilator medication used in the past 24 hours
- •Symptom onset ≥72 hours
- •Inability to wear a face mask
- •Inability to obtain adequate baseline echocardiogram
研究组 & 干预措施
Supplemental oxygen delivered by facemask
Patients with acute PE will be randomized to breathing supplemental oxygen by non-rebreather face mask first.
Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.
干预措施: Oxygen Therapy (Drug)
Supplemental oxygen delivered by facemask
Patients with acute PE will be randomized to breathing supplemental oxygen by non-rebreather face mask first.
Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.
干预措施: Non-rebreather mask (Device)
Room air delivered by facemask
Patients with acute PE will be randomized to breathing room air by non-rebreather face mask first.
Subjects will alternate treatments (supplemental oxygen or room air) every 30 minutes for 90 minutes (e.g. T=30, T=60, T=90) and then will maintain their treatment (oxygen or room air) for a total of 180 minutes.
干预措施: Non-rebreather mask (Device)
结局指标
主要结局
Pulmonary artery systolic pressure (PASP)
时间窗: 180 minutes after study treatment (supplemental oxygen) or placebo (room air)
PASP is measured on bedside echocardiogram
次要结局
- Right ventricular to left ventricular ratio (RV/LV)(180 minutes after study treatment (supplemental oxygen) or placebo (room air))
- Concentrations of circulating metabolites and metabolic profiles measured by high-throughput metabolomic assays(180 minutes after study treatment (supplemental oxygen) or placebo (room air))
研究者
Christopher Kabrhel MD MPH
Professor of Emergency Medicine; Attending Physician
Massachusetts General Hospital