Clinical trial NCT01463514: Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension,
NIRS,
Near-infrared spectroscopy,
cerebral tissue oxygenation,
cerebral blood flow
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2011-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline cerebral tissue oxygenation (in %) during right heart catheterization and after 3 month
timeFrame: First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)
measure: Changes in cerebral blood flow (in % from baseline) during right heart catheterization and after 3 month
timeFrame: First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Pneumology
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
affiliation: University Hospital Zurich, Division of Pneumology
name: Silvia Ulrich Somaini, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muller-Mottet S, Hildenbrand FF, Keusch S, Hasler E, Maggiorini M, Speich R, Bloch KE, Ulrich S. Effects of exercise and vasodilators on cerebral tissue oxygenation in pulmonary hypertension. Lung. 2015 Feb;193(1):113-20. doi: 10.1007/s00408-014-9667-5. Epub 2014 Nov 21.