Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Pressure waveform
研究概览
简要总结
Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG), can be used to identify detectable oscillations that are correlated with the mean, the diastolic and the systolic pressure values of the pulmonary artery, as measured using the gold-standard Swan-Ganz method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart Failure patient scheduled for right heart catheterization (Swan-Ganz)
- •Age range: 18 - 80 years
- •Pulmonary artery systolic pressure values ≤50 mmHg according to Swan - Ganz measurement
- •Able and willing to sign informed consent
排除标准
- •History or current diagnosis of asthma or any other significant pulmonary disease
- •Jugular access site
- •Atrial fibrillation
- •Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
- •Requirement for any ventilator support (including CPAP or BPAP)
- •Use of long-term oxygen therapy
- •Known upper airway obstruction
- •Known susceptibility to pneumothorax or pneumothorax in the medical history
- •Chest surgery or pacemaker implantation in the prior 6 months
- •Significant primary valvular disease
- •Major cardiovascular event within the prior 3 months
- •Current heavy smoker (more than one pack per day)
- •Any diagnosed respiratory tract infection (including upper respiratory tract), airway or lung disease or COPD exacerbation in the prior 3 months
- •Female patient pregnant or breast-feeding or planning to be pregnant in the next year
- •Diagnosis of Obstructive Sleep Apnea
- •Unexplained muscle weakness. Unable to comfortably lie down for 30 minutes
- •Current hospitalization due to CHF deterioration
- •Patients with a Body Mass Index (BMI) ≥ 40kg/m2
- •Any condition that the PI believes could interfere with the intent of the study or would make participation not in the best interest of the patient
结局指标
主要结局
Pressure waveform
时间窗: 15 minutes
Correlation between specific changes observed in the pressure waveform recorded by the SureMedix Device and the mean, diastolic and systolic pressure values of the pulmonary artery as measured using the gold-standard Swan-Ganz method.
次要结局
未报告次要终点