Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension

November 13, 2015 updated by: University of Zurich

Noninvasive Determination Of Cerebral Tissue Oxygenation And Cerebral Blood Flow With Near-Infrared Spectroscopy In Patients With Pulmonary Hypertension Undergoing Right Heart Catheterization

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland
        • University Hospital Zurich, Pneumology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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
First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silvia Ulrich Somaini, MD, University Hospital Zurich, Division of Pneumology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIRS_Study_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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