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临床试验/NCT01463514
NCT01463514已完成不适用

Noninvasive Determination Of Cerebral Tissue Oxygenation And Cerebral Blood Flow With Near-Infrared Spectroscopy In Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization

University of Zurich1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Changes from baseline cerebral tissue oxygenation (in %) during right heart catheterization and after 3 month

研究概览

简要总结

To study the effect of acute pulmonary vasodilatation on cerebral tissue oxygenation (CTO) and cerebral blood flow (CBF) as indicator for cerebrovascular autoregulation in comparison to the effects of supplemental oxygen, decreased carbon dioxide by hyperventilation and exercise in patients with pulmonary hypertension (PH) undergoing clinically indicated right heart catheterisation (RHC).

Oxygenation and hemodynamic parameters will be assessed during RHC according to standard procedures. Non-invasive near infrared spectroscopy (NIRS) and a nasal canula will be additionally applied to measure CTO, CBF and endtidal CO2 (EtCO2). All parameters will be obtained at rest breathing room air, during an oxygen challenge, during standardized hyperventilation, under vasodilatation testing and during exercise in random, single-blinded sequences (except for exercise and hyperventilation). Pulmonary, systemic and cerebral oxygenation parameters and hemodynamics will be correlated with each other and functional class, quality of life, exercise and cognitive assessments at the time of the RHC and after three month.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

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

  • •Inclusion criteria are age 18 years or older, to be scheduled for RHC due to suspected or known PH and the ability to give informed consent. Both genders will be accepted.

排除标准

  • •Exclusion criteria are: inability to follow the study due to language or cognitive problems (e.g. a major active psychiatric disorders, prior traumatic brain injury, and neurologic disease), dementia on the basis of a Mini Mental State Test and pregnant women.

研究组 & 干预措施

AIR

Experimental

Randomization sequences according to modified catheter protocol.

  1. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen

干预措施: Right heart catheterization (Procedure)

AIR

Experimental

Randomization sequences according to modified catheter protocol.

  1. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen

干预措施: Near-infrared spectroscopy (Procedure)

NO

Experimental

Randomization sequences according to modified catheter protocol.

1.Nitric Oxygen 2. AIR 3. Target Oxygen(88-90%) 4. 100% Oxygen

干预措施: Right heart catheterization (Procedure)

NO

Experimental

Randomization sequences according to modified catheter protocol.

1.Nitric Oxygen 2. AIR 3. Target Oxygen(88-90%) 4. 100% Oxygen

干预措施: Near-infrared spectroscopy (Procedure)

Oxygen

Experimental

Randomization sequences according to modified catheter protocol.

  1. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%)

干预措施: Right heart catheterization (Procedure)

Oxygen

Experimental

Randomization sequences according to modified catheter protocol.

  1. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%)

干预措施: Near-infrared spectroscopy (Procedure)

Target Oxygen

Experimental

Randomization sequences according to modified catheter protocol.

  1. Target Oxygen (88-90%) 2. 100% Oxygen 3. NO 4. AIR

干预措施: Right heart catheterization (Procedure)

Target Oxygen

Experimental

Randomization sequences according to modified catheter protocol.

  1. Target Oxygen (88-90%) 2. 100% Oxygen 3. NO 4. AIR

干预措施: Near-infrared spectroscopy (Procedure)

结局指标

主要结局

Changes from baseline cerebral tissue oxygenation (in %) during right heart catheterization and after 3 month

时间窗: First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)

Acute effects (deviation from baseline measurements in % of oxygenated blood) of oxygen challenge, hyperventilation and vasodilator testing during right heart catheterization on cerebral tissue oxygenation in patients with pulmonay hypertension

Changes in cerebral blood flow (in % from baseline) during right heart catheterization and after 3 month

时间窗: First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)

Acute effects (deviation from baseline measurements in % from baseline) of oxygen challenge, hyperventilation and vasodilator testing during right heart catheterization on cerebral blood flow in patients with pulmonay hypertension

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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