An interventional study of Right heart catheterization and Near-infrared spectroscopy in Pulmonary Hypertension, sponsored by University of Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-16.
Sponsored by University of Zurich · Not applicable, Interventional, and Diagnostic
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.
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's planned enrollment of 20 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →University of Zurich is the lead sponsor of 1,030 studies on the registry; 130 are open to participants now.
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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.
Randomization sequences according to modified catheter protocol. 1. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen
Procedure: Right heart catheterization · Procedure: Near-infrared spectroscopy
Randomization sequences according to modified catheter protocol. 1.Nitric Oxygen 2. AIR 3. Target Oxygen(88-90%) 4. 100% Oxygen
Procedure: Right heart catheterization · Procedure: Near-infrared spectroscopy
Randomization sequences according to modified catheter protocol. 1. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%)
Procedure: Right heart catheterization · Procedure: Near-infrared spectroscopy
Randomization sequences according to modified catheter protocol. 1. Target Oxygen (88-90%) 2. 100% Oxygen 3. NO 4. AIR
Procedure: Right heart catheterization · Procedure: Near-infrared spectroscopy
Oxygenation and hemodynamic parameters will be assessed during RHC according to standard procedures. All measurements will be noted as usual for PH assessment including: at rest breathing room air, during an oxygen challenge, under vasodilator testing with NO and/or during exercise. Room air, supplemental oxygen and NO will be applied over common breathing mask while patient is in a supine position. Oxygen will be taken as usual from the common adjustable hospital wall access, NO will be taken according to usual clinical practice during RHC from a gas cylinder connected to a reservoir, where adequate ppm concentration can be regulated. A dose of 40 ppm NO will be used according to common practise. Oxygen delivery to maintain the peripheral oxygen saturation between 88% and 90% will be adjusted over a 3 minute period of time.
For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.
Also known as: INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USA
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
Time frame: First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)
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
Time frame: First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)
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University of Zurich