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Clinical Trials/NCT01463514
NCT01463514
Completed
Not Applicable

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 site in 1 country20 target enrollmentSeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
University of Zurich
Enrollment
20
Locations
1
Primary Endpoint
Changes from baseline cerebral tissue oxygenation (in %) during right heart catheterization and after 3 month
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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