Pulmonary HypertensionNCT01463514
Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension
A study testing Right heart catheterization and Near-infrared spectroscopy in people with Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Right heart catheterization and Near-infrared spectroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2011to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Right heart catheterization, Near-infrared spectroscopy
- Keywords
- Pulmonary Hypertension,, NIRS,, Near-infrared spectroscopy,, cerebral tissue oxygenation,, cerebral blood flow
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right heart catheterizationProcedure or surgery
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 spectroscopyProcedure or surgery
Also called INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USA
For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.
| Study group | Role | What they receive |
|---|---|---|
| AIR | Experimental | Randomization sequences according to modified catheter protocol.
1. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen Receives: Procedure: Right heart catheterization; Procedure: 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 Receives: Procedure: Right heart catheterization; Procedure: Near-infrared spectroscopy |
| Oxygen | Experimental | Randomization sequences according to modified catheter protocol.
1. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%) Receives: Procedure: Right heart catheterization; Procedure: 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 Receives: Procedure: Right heart catheterization; Procedure: Near-infrared spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: First measurement (day 1 = day of examination) during right heart catherization and after 3 month (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital ZuerichSilvia Ulrich Somaini, MD, Principal investigator, University Hospital Zurich, Division of Pneumology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01463514
- Sponsor's protocol ID
- NIRS_Study_1
- Status last verified
- Nov 2015
- First submitted
- 18 Oct 2011
- Last updated
- 16 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25413133
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01463514
- Acronym / sponsor ID
- NIRS_Study_1
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension,, NIRS,, Near-infrared spectroscopy,, cerebral tissue oxygenation,, cerebral blood flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AIR | Experimental | Procedure: Right heart catheterization, Procedure: Near-infrared spectroscopyRandomization sequences according to modified catheter protocol. 1. AIR 2. Target Oxygen(88-90%) 3. 100% Oxygen 4. Nitric Oxygen |
| NO | Experimental | Procedure: Right heart catheterization, Procedure: Near-infrared spectroscopyRandomization sequences according to modified catheter protocol. 1.Nitric Oxygen 2. AIR 3. Target Oxygen(88-90%) 4. 100% Oxygen |
| Oxygen | Experimental | Procedure: Right heart catheterization, Procedure: Near-infrared spectroscopyRandomization sequences according to modified catheter protocol. 1. 100% Oxygen 2. NO 3. AIR 4. Target Oxygen (88-90%) |
| Target Oxygen | Experimental | Procedure: Right heart catheterization, Procedure: Near-infrared spectroscopyRandomization sequences according to modified catheter protocol. 1. Target Oxygen (88-90%) 2. 100% Oxygen 3. NO 4. AIR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right heart catheterizationOxygenation 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 or surgery | AIR, NO, Oxygen, Target Oxygen |
| Near-infrared spectroscopyAlso: INVOS® device (SOMANETICS CORPORATION, TROY, MICHIGAN, USAFor study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization. | Procedure or surgery | AIR, NO, Oxygen, Target Oxygen |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Derived from this study: PubMed 25413133Muller-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
Silvia Ulrich Somaini, MD principal investigator
University Hospital Zurich, Division of Pneumology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right heart catheterization and Near-infrared spectroscopy in people with Pulmonary Hypertension, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01463514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2015.