NCT01463514

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 2, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

November 16, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

October 18, 2011

Last Update Submit

November 13, 2015

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension,NIRS,Near-infrared spectroscopy,cerebral tissue oxygenation,cerebral blood flow

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)

Study Arms (4)

AIR

EXPERIMENTAL

Randomization sequences according to modified catheter protocol. 1\. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen

Procedure: Right heart catheterizationProcedure: Near-infrared spectroscopy

NO

EXPERIMENTAL

Randomization sequences according to modified catheter protocol. 1.Nitric Oxygen 2. AIR 3. Target Oxygen(88-90%) 4. 100% Oxygen

Procedure: Right heart catheterizationProcedure: Near-infrared spectroscopy

Oxygen

EXPERIMENTAL

Randomization sequences according to modified catheter protocol. 1\. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%)

Procedure: Right heart catheterizationProcedure: Near-infrared spectroscopy

Target Oxygen

EXPERIMENTAL

Randomization sequences according to modified catheter protocol. 1\. Target Oxygen (88-90%) 2. 100% Oxygen 3. NO 4. AIR

Procedure: Right heart catheterizationProcedure: Near-infrared spectroscopy

Interventions

Right heart catheterizationPROCEDURE

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.

AIRNOOxygenTarget Oxygen
Near-infrared spectroscopyPROCEDURE

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
AIRNOOxygenTarget Oxygen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Pneumology

Zurich, Switzerland

Location

Related Publications (1)

  • 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.

    PMID: 25413133DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

  • Silvia Ulrich Somaini, MD

    University Hospital Zurich, Division of Pneumology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2011

First Posted

November 2, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

November 16, 2015

Record last verified: 2015-11

Locations

CH(1)