Study to Evaluate the Role of Inhaled Nitric Oxide (iNO) on Pulmonary Hemodynamics in Patients With Intermediate/Submassive and Massive Pulmonary Embolism (PE)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- right atrial pressure (RAP)
研究概览
简要总结
A single center study to evaluate the effect of inhaled nitric oxide (iNO) on pulmonary dynamics in patients presenting with imaging confirmed intermediate/submassive or massive pulmonary embolism (PE). The target enrollment is 20 subjects at Ronald Reagan UCLA Medical Center. PE patients undergoing catheter-based intervention will be administered iNO during their intervention and pulmonary hemodynamic measurement will be measured before, during, and after iNO administration (Invasive Cohort). Patients who are not undergoing catheter-based intervention will also be administered iNO and will have pulmonary hemodynamics, blood pressure, and heart rate measured non-invasively (Non-Invasive Cohort).
详细描述
This is a single center study to evaluate patients presenting with imaging confirmed intermediate/submassive or massive pulmonary embolism (PE). The investigators anticipate to enroll a total of 20-25 subjects at Ronald Reagan UCLA Medical Center.
After informed consent is obtained, the subject will proceed under one of two study intervention arms depending on his or her treatment plan. If the patient requires invasive treatment such as interventional thrombectomy or catheter-directed thrombolysis (CDT), the participant will be enrolled in the interventional radiology arm (invasive cohort). If the patient requires non-invasive treatment such as anticoagulation therapy, deep vein thrombosis (DVT) thrombectomy, or inferior vena cava (IVC) filter, the participant will be enrolled in the non-intervention arm (non-invasive cohort).
Interventional Radiology Arm (Invasive Cohort):
The following procedure will be performed:
Interventional radiology (IR) will perform a right heart catheterization (RHC) as part of a planned IR procedure. Patient arrives in the IR suite and is positioned flat with head of bed between flat and 45 degrees. O2 amount and modality, blood pressure, pressor name, dose, and rate will be recorded. If the patient is intubated, the sedation/analgesia drug name(s), dose(s), and rate(s) will be recorded. If the patient is not intubated, name and dose amount of sedation will be recorded. Arterial blood gas will be obtained if an A-line is placed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years of age.
- •The patient or patient's surrogate decision maker must understand and sign the informed consent form (ICF).
- •Hospitalized (Emergency Room (ER) or inpatient) with:
- •Imaging (computed tomography pulmonary angiography (CTPA) or ventilation/perfusion (VQ) lung scan) proven acute pulmonary embolism (PE)
- •PE meets the following intermediate risk PE criteria (or massive, see below):
- •Troponin > .1 AND
- •Imaging (computed tomography (CT) or transthoracic echocardiogram (TTE)) signs of RV compromise (at least 1 of the following):
- •RV:LV>1 on TTE or CTPA OR RV dilation (TTE or CTPA OR RV dysfunction on TTE.
- •Massive PE
- •Intensive care unit (ICU) level of care (Patient moving to ICU, ICU level of care in ER, or currently in ICU)
- •Ability to comply with study protocol in investigator's judgement
排除标准
- •Pregnancy or breastfeeding
- •Inability to administer iNO through current mode of O2 delivery (i.e. BiPAP)
- •Active hemoptysis
- •Known allergy to iNO.
- •Any serious medical condition of lab abnormality that, in the investigator's judgement, precludes the patient's safe participation in the study.
- •Methemoglobin reductase deficiency
- •Unable to obtain consent or patient or patient surrogate decision maker declines
- •Patients already on iNO prior to study enrollment
研究组 & 干预措施
Interventional Radiology Arm (Invasive Cohort)
Interventional radiology (IR) will perform a right heart catheterization (RHC) as part of a planned IR procedure.
Bedside apical 4 chamber view (RV:LV ratio) will be recorded using an ultrasound device, and noninvasive RV data will be obtained with Edwards ClearSight system and Edwards EV1000 clinical platform.
The Butterfly iQ+ (one possible ultrasound device which may be used) is a single-probe, whole-body ultrasound device.
After initial measurements, inhaled nitric oxide (iNO) will be administered at 30 ppm for 3 minutes. The same measurements will be obtained/calculated before, during iNO administration, and after iNO has been withheld for 2 minutes.
干预措施: inhaled nitric oxide (iNO) (Drug)
Non-intervention Arm (Non-invasive Cohort)
Vitals including O2 amount and modality, blood pressure, pressor name, dose, and rate will be recorded. If the patient is intubated, the name, dose, and rate of sedation and analgesia will be recorded. If the patient is not intubated, name and dose amount of sedation will be recorded. Arterial blood gas will be obtained if an A-line is placed. Bedside apical 4 chamber view will be recorded (RV:LV ratio) with an ultrasound device, and noninvasive RV data will be obtained with Edwards ClearSight system and Edwards EV1000 clinical platform. This data will be obtained before, during iNO administration, and after iNO has been withheld for 2 minutes.
干预措施: inhaled nitric oxide (iNO) (Drug)
结局指标
主要结局
right atrial pressure (RAP)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
right atrial pressure (RAP) in mmHg
cardiac output (CO) (by Fick and Thermodilution)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
Cardiac Output (CO) is the amount of blood the heart pumps from each ventricle per minute. It is usually expressed in litres per minute (L/min).
right ventricular pressure (RVP)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
right ventricular pressure (RVP) in mmHg
pulmonary arterial pressure (PAP)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
pulmonary arterial pressure (PAP) in mmHg
pulmonary capillary wedge pressure (PCWP)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
pulmonary capillary wedge pressure (PCWP) in mmHg
cardiac index (CI) (by Fick and Thermodilution)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
mixed venous O2
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
mixed venous O2 in %
central venous O2
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
central venous O2 in %
systemic PaO2
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
systemic PaO2 in mmHg
heart rate (HR) (measured noninvasively)
时间窗: measured noninvasively after administration of inhaled nitric oxide (iNO)
The number of heartbeats per unit of time, usually per minute. Measured in beats per minute (BPM)
systolic blood pressure (SBP)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
Systolic Blood Pressure in mmHg
diastolic blood pressure (DBP)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
Diastolic Blood Pressure in mmHg
mean arterial pressure (MAP)
时间窗: measured invasively during a right heart catheterization (RHC) after administration of iNO
mean arterial pressure (MAP) in mmHg
cardiac index (CI) (measured noninvasively)
时间窗: measured noninvasively after administration of inhaled nitric oxide (iNO)
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
blood pressure (BP) (measured noninvasively)
时间窗: measured noninvasively after administration of inhaled nitric oxide (iNO)
The pressure of the blood in the circulatory system, often measured for diagnosis since it is closely related to the force and rate of the heartbeat and the diameter and elasticity of the arterial walls. Systolic Blood Pressure in mmHg Diastolic Blood Pressure in mmHg
right atrial pressure (RAP)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
right atrial pressure (RAP) in mmHg
right atrial pressure (RAP)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
right atrial pressure (RAP) in mmHg
right ventricular pressure (RVP)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
right ventricular pressure (RVP) in mmHg
right ventricular pressure (RVP)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
right ventricular pressure (RVP) in mmHg
pulmonary arterial pressure (PAP)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
pulmonary arterial pressure (PAP) in mmHg
pulmonary arterial pressure (PAP)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
pulmonary arterial pressure (PAP) in mmHg
pulmonary capillary wedge pressure (PCWP)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
pulmonary capillary wedge pressure (PCWP) in mmHg
pulmonary capillary wedge pressure (PCWP)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
pulmonary capillary wedge pressure (PCWP) in mmHg
cardiac output (CO) (by Fick and Thermodilution)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
Cardiac Output (CO) is the amount of blood the heart pumps from each ventricle per minute. It is usually expressed in litres per minute (L/min).
cardiac output (CO) (by Fick and Thermodilution)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
Cardiac Output (CO) is the amount of blood the heart pumps from each ventricle per minute. It is usually expressed in litres per minute (L/min).
cardiac index (CI) (by Fick and Thermodilution)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
cardiac index (CI) (by Fick and Thermodilution)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
mixed venous O2
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
mixed venous O2 in %
mixed venous O2
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
mixed venous O2 in %
central venous O2
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
central venous O2 in %
central venous O2
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
central venous O2 in %
systemic PaO2
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
systemic PaO2 in mmHg
systemic PaO2
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
systemic PaO2 in mmHg
systolic blood pressure (SBP)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
Systolic Blood Pressure in mmHg
systolic blood pressure (SBP)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
Systolic Blood Pressure in mmHg
diastolic blood pressure (DBP)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
Diastolic Blood Pressure in mmHg
diastolic blood pressure (DBP)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
Diastolic Blood Pressure in mmHg
mean arterial pressure (MAP)
时间窗: measured invasively during a right heart catheterization (RHC) before administration of iNO
mean arterial pressure (MAP) in mmHg
mean arterial pressure (MAP)
时间窗: measured invasively during a right heart catheterization (RHC) during administration of iNO
mean arterial pressure (MAP) in mmHg
blood pressure (BP) (measured noninvasively)
时间窗: measured noninvasively before administration of inhaled nitric oxide (iNO)
The pressure of the blood in the circulatory system, often measured for diagnosis since it is closely related to the force and rate of the heartbeat and the diameter and elasticity of the arterial walls. Systolic Blood Pressure in mmHg Diastolic Blood Pressure in mmHg
blood pressure (BP) (measured noninvasively)
时间窗: measured noninvasively during administration of inhaled nitric oxide (iNO)
The pressure of the blood in the circulatory system, often measured for diagnosis since it is closely related to the force and rate of the heartbeat and the diameter and elasticity of the arterial walls. Systolic Blood Pressure in mmHg Diastolic Blood Pressure in mmHg
heart rate (HR) (measured noninvasively)
时间窗: measured noninvasively before administration of inhaled nitric oxide (iNO)
The number of heartbeats per unit of time, usually per minute. Measured in beats per minute (BPM)
heart rate (HR) (measured noninvasively)
时间窗: measured noninvasively during administration of inhaled nitric oxide (iNO)
The number of heartbeats per unit of time, usually per minute. Measured in beats per minute (BPM)
cardiac index (CI) (measured noninvasively)
时间窗: measured noninvasively before administration of inhaled nitric oxide (iNO)
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
cardiac index (CI) (measured noninvasively)
时间窗: measured noninvasively during administration of inhaled nitric oxide (iNO)
Cardiac index (CI) is the cardiac output proportional to the body surface area (BSA). The unit of measurement is litres per minute per square metre (L/min/m2).
次要结局
未报告次要终点
研究者
Rajan Saggar
Professor of Medicine
University of California, Los Angeles