Standardized Goal-Directed Vs. Self-Directed Valsalva Maneuver for the Assessment of Patent Foramen Ovale
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 488
- 试验地点
- 2
- 主要终点
- Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver.
研究概览
简要总结
Ischemic stroke represents a major public health issue, leading to significant disabilities and deaths worldwide. When no clear cause for stroke is found following a comprehensive cardiovascular evaluation (no atrial fibrillation, cardiac masses, or atherosclerosis) i.e. cryptogenic stroke, it is recommended to search for a patent foramen ovale (PFO), especially in young patients. It is estimated that cryptogenic stroke accounts for 30% to 40% of ischemic strokes. Transthoracic echocardiography (TTE) with bubble study at rest and during Valsalva maneuver is the reference method for the diagnosis of PFO. The treatment of PFO using a closure device has demonstrated a significant reduction in recurrent stroke events in patients with PFO and cryptogenic stroke. The Valsalva maneuver is currently achieved using self-directed maneuver i.e. patients are instructed to ''bear down'' or ''strain as if attempting to move your bowels.'' These instructions are subjective and depend largely on individuals understanding and effort. A Goal-Directed Valsalva Maneuver using a manometer has been shown to be a more reproducible way to perform the Valsalva achieving more sensitivity in different settings such as hypertrophic cardiomyopathy but its incremental diagnostic value for the detection of PFO has not been yet evaluated.
The aim of the present study is to compare the sensibility and specificity of two methods of Valsalva maneuver for the detection of PFO. We hypothesize that Goal-Directed Valsalva Maneuver will significantly increase the detection rate of PFO compared to Self-Directed Valsalva Maneuver.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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 referred for a clinically indicated TTE and bubble study
排除标准
- •Inability to provide informed consent
- •Inability to insert an IV line
- •Inability to perform a Self-Directed Valsalva maneuver
- •Patient wishing to keep his mask on
研究组 & 干预措施
Control - standard of care: Self-Directed Valsalva maneuver
The Valsalva maneuver is performed by the patient taking a normal (or deep) inspiration, followed by forceful expiration against a closed airway for up to 15 to 20 sec and then release of the expiratory effort on entry of saline into the right atrium.
干预措施: Experimental: Intervention arm: Goal-Directed Valsalva maneuver (Device)
Control - standard of care: Self-Directed Valsalva maneuver
The Valsalva maneuver is performed by the patient taking a normal (or deep) inspiration, followed by forceful expiration against a closed airway for up to 15 to 20 sec and then release of the expiratory effort on entry of saline into the right atrium.
干预措施: Control - standard of care: Self-Directed Valsalva maneuver (Device)
Intervention arm: Goal-Directed Valsalva maneuver
For the Goal directed Valsalva maneuver, the same method patients are instructed to blow into a plastic pipe connected to the manometer device, in order to reach a pressure of 40 mmHg for at least 5 seconds. Then patients are instructed to exhale quickly.
干预措施: Experimental: Intervention arm: Goal-Directed Valsalva maneuver (Device)
Intervention arm: Goal-Directed Valsalva maneuver
For the Goal directed Valsalva maneuver, the same method patients are instructed to blow into a plastic pipe connected to the manometer device, in order to reach a pressure of 40 mmHg for at least 5 seconds. Then patients are instructed to exhale quickly.
干预措施: Control - standard of care: Self-Directed Valsalva maneuver (Device)
结局指标
主要结局
Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver.
时间窗: From enrollment to the end of echocardiogram (40 minutes from enrollment).
次要结局
- Rate of large shunt positive bubble study.(From enrollment to the end of echocardiogram (40 minutes from enrollment).)
- Rate of detection of PFO by Self-Directed Valsalva Maneuver and Goal-Directed Valsalva Maneuver in women and in men.(From enrollment to the end of echocardiogram (40 minutes from enrollment).)
