Pulmonary Hypertension Clinical Trial
Official title:
Noninvasive Determination Of Cerebral Tissue Oxygenation And Cerebral Blood Flow With Near-Infrared Spectroscopy In Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization
Verified date | November 2015 |
Source | University of Zurich |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | June 2014 |
Est. primary completion date | June 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: 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. Exclusion criteria: 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Zurich, Pneumology | Zurich |
Lead Sponsor | Collaborator |
---|---|
University of Zurich |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from baseline cerebral tissue oxygenation (in %) during right heart catheterization and after 3 month | 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 | First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up) | No |
Primary | Changes in cerebral blood flow (in % from baseline) during right heart catheterization and after 3 month | 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 | First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up) | No |
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