Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Zurich.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01463514
First received: October 18, 2011
Last updated: November 1, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Pulmonary Hypertension
Procedure: Right heart catheterization
Procedure: Near-infrared spectroscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: September 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AIR

Randomization sequences according to modified catheter protocol.

1. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen

Procedure: Right heart catheterization
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.
Procedure: Near-infrared spectroscopy
For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.
Other Name: INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USA
Experimental: NO

Randomization sequences according to modified catheter protocol.

1.Nitric Oxygen 2. AIR 3. Target Oxygen(88-90%) 4. 100% Oxygen

Procedure: Right heart catheterization
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.
Procedure: Near-infrared spectroscopy
For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.
Other Name: INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USA
Experimental: Oxygen

Randomization sequences according to modified catheter protocol.

1. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%)

Procedure: Right heart catheterization
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.
Procedure: Near-infrared spectroscopy
For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.
Other Name: INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USA
Experimental: Target Oxygen

Randomization sequences according to modified catheter protocol.

1. Target Oxygen (88-90%) 2. 100% Oxygen 3. NO 4. AIR

Procedure: Right heart catheterization
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.
Procedure: Near-infrared spectroscopy
For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.
Other Name: INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01463514

Contacts
Contact: Florian Hildenbrand, MD florian.hildenbrand@usz.ch

Locations
Switzerland
University Hospital Zurich, Pneumology Recruiting
Zurich, Switzerland
Principal Investigator: Silvia Ulrich Somaini, MD         
Sub-Investigator: Florian Hildenbrand, MD         
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
Principal Investigator: Silvia Ulrich Somaini, MD University Hospital Zurich, Division of Pneumology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01463514     History of Changes
Other Study ID Numbers: NIRS_Study_1
Study First Received: October 18, 2011
Last Updated: November 1, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Pulmonary Hypertension,
NIRS,
Near-infrared spectroscopy,
cerebral tissue oxygenation,
cerebral blood flow

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014