Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension

Not Applicable

Completed

• Conditions: Pulmonary Hypertension
• Interventions: Procedure: Right heart catheterization; Procedure: Near-infrared spectroscopy

• Registration Number: NCT01463514
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-18
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-02
• Primary Completion: 2013-06
• Study Completion: 2014-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-13
• Last Update Posted: 2015-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Target Oxygen	Near-infrared spectroscopy	Randomization sequences according to modified catheter protocol. 1. Target Oxygen (88-90%) 2. 100% Oxygen 3. NO 4. AIR
AIR	Right heart catheterization	Randomization sequences according to modified catheter protocol. 1. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen
AIR	Near-infrared spectroscopy	Randomization sequences according to modified catheter protocol. 1. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen
NO	Near-infrared spectroscopy	Randomization sequences according to modified catheter protocol. 1.Nitric Oxygen 2. AIR 3. Target Oxygen(88-90%) 4. 100% Oxygen
Oxygen	Near-infrared spectroscopy	Randomization sequences according to modified catheter protocol. 1. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%)
NO	Right heart catheterization	Randomization sequences according to modified catheter protocol. 1.Nitric Oxygen 2. AIR 3. Target Oxygen(88-90%) 4. 100% Oxygen
Oxygen	Right heart catheterization	Randomization sequences according to modified catheter protocol. 1. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%)
Target Oxygen	Right heart catheterization	Randomization sequences according to modified catheter protocol. 1. Target Oxygen (88-90%) 2. 100% Oxygen 3. NO 4. AIR

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Zurich, Pneumology; 🇨🇭 Zurich, Switzerland