Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension

NCT ID: NCT01463514

Last Updated: 2015-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

AIR

Randomization sequences according to modified catheter protocol.

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

Group Type: EXPERIMENTAL

Right heart catheterization

Intervention Type: PROCEDURE

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.

Near-infrared spectroscopy

Intervention Type: PROCEDURE

For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.

NO

Randomization sequences according to modified catheter protocol.

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

Group Type: EXPERIMENTAL

Right heart catheterization

Intervention Type: PROCEDURE

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.

Near-infrared spectroscopy

Intervention Type: PROCEDURE

For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.

Oxygen

Randomization sequences according to modified catheter protocol.

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

Group Type: EXPERIMENTAL

Right heart catheterization

Intervention Type: PROCEDURE

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.

Near-infrared spectroscopy

Intervention Type: PROCEDURE

For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.

Target Oxygen

Randomization sequences according to modified catheter protocol.

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

Group Type: EXPERIMENTAL

Right heart catheterization

Intervention Type: PROCEDURE

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.

Near-infrared spectroscopy

Intervention Type: PROCEDURE

For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.

Interventions

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.

Intervention Type: PROCEDURE

Near-infrared spectroscopy

For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.

Intervention Type: PROCEDURE

Other Intervention Names

INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USA

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

01 Studienregister MasterAdmins

Role: STUDY_DIRECTOR

UniversitaetsSpital Zuerich

Silvia Ulrich Somaini, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Division of Pneumology

Locations

University Hospital Zurich, Pneumology

Zurich, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 25413133 (View on PubMed)

Other Identifiers

NIRS_Study_1

Identifier Type: -

Identifier Source: org_study_id