Cardiovascular DiseaseNCT00939224
Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
An observational study of Cardiovascular Disease, run by Nonin Medical, Inc at 3 sites in United States.
Trial summary
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization. Read more about this study
- Who is it for?
- Ages Up to 12 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Model 7600 Regional Oximeter System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2009to Aug 2011
- Phase
- Observational
- 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 Up to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with cardiovascular disease (acquired or congenital; cyanotic or acyanotic; unrepaired, palliated or fully repaired) requiring cardiac catheterization to diagnose or treat the disease will be eligible for study.
Who may be able to join
- The subject is male or female;
- The subject is of any racial or ethnic group;
- The subject is between 0 days and 12 years of age;
- Is less than 40 kg;
- The subject is scheduled for a cardiac catheterization for treatment or diagnosis of a cardiovascular disease;
- The scheduled cardiac catheterization includes catheter placements in the central venous circulation and central arterial circulation, or catheter placement in the central venous circulation with a pre-existing arterial catheter;
- The subject is American Society Anesthesiologist (ASA) status 1 through 4; and
- The subject's legally authorized representative has given written informed consent to participate in the study and, when appropriate, the subject has given assent to participate.
Who cannot join
- Is greater than twelve (12) years of age;
- Has pre-existing allergies to adhesive tapes or adhesives on neonatal ECG pads;
- Has pre-existing skin condition at the site where the Nonin cerebral oximeter sensor will be placed (e.g., eczema, dermatitis);
- Has craniofacial disease preventing application of the sensor to the forehead;
- Has sickle cell anemia or other hemoglobinopathy;
- Has disease of the cerebrovasculature including the jugular or carotid vessels;
Show all 11Show fewer
- Was previously on ECMO involving the carotid or jugular vessels that could have resulted in disease or ligation;
- Is not able to be in a supine position with cardiac catheterization laboratory table angle zero degrees with a neutral neck position at zero degrees rotation;
- Has acute neurological injury (seizure, stroke, encephalopathy, meningoencephalitis currently or within the past 10 days), or a structural brain lesion (eg, arteriovenous malformation, cyst) in the optical field beneath the sensor;
- Has an emergency, life-threatening condition (American Society of Anesthesiologists Physical status 5 or 6) impacting the ability to obtain informed consent;
- Or has another condition, which in the opinion of the principal investigator would not be suitable for participation in the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rush University Medical Center
Chicago, Illinois, 60612
Cincinnati Children Hospital Medical Center
Cincinnati, Ohio, 45229
Stanford University School of Medicine
Stanford, California, 94305-5640
About this study
Official title: Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.
- Conditions
- Cardiovascular Disease
- Being tested
- Model 7600 Regional Oximeter System
- Keywords
- Near-infrared spectroscopy (NIRS), Regional oxygen saturation, Pediatrics, Cardiac catheterization, Congenital heart disease
- Medical subject headings
- Cardiovascular Diseases, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Model 7600 Regional Oximeter SystemDevice
Non-invasive regional oxygen saturation measurements
| Study group | Role | What they receive |
|---|---|---|
| Cohort Phase 1 | Cardiac Catheterization Receives: Device: Model 7600 Regional Oximeter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success of the validation and calibration will be assessed through the Arms statistic.
Measured: Single visit
Secondary outcomes (1)
Tissue (somatic) sensor readings will be described using the descriptive statistics.
Measured: Single Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2011
- Study completionAug 2011
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 Cardiovascular DiseaseStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nonin Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lori M Mitchell, RN, BSN, Study director, Nonin Medical, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00939224
- Sponsor's protocol ID
- QATP1542
- Status last verified
- Aug 2011
- First submitted
- 10 Jul 2009
- Last updated
- 25 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Kreeger RN, Ramamoorthy C, Nicolson SC, Ames WA, Hirsch R, Peng LF, Glatz AC, Hill KD, Hoffman J, Tomasson J, Kurth CD. Evaluation of pediatric near-infrared cerebral oximeter for cardiac disease. Ann Thorac Surg. 2012 Nov;94(5):1527-33. doi: 10.1016/j.athoracsur.2012.05.096. Epub 2012 Aug 2.
PubMed 22858270
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT00939224
- Acronym / sponsor ID
- QATP1542
- Conditions
- Cardiovascular Disease
- Keywords
- Near-infrared spectroscopy (NIRS), Regional oxygen saturation, Pediatrics, Cardiac catheterization, Congenital heart disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nonin Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Jul 2009 (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.
The purpose of this study is to validate the Nonin Near-infrared spectroscopy (NIRS) device to measure regional oxygen saturation in a cohort of children with cardiovascular disease undergoing cardiac catheterization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort Phase 1 | – | Device: Model 7600 Regional Oximeter SystemCardiac Catheterization |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with cardiovascular disease (acquired or congenital; cyanotic or acyanotic; unrepaired, palliated or fully repaired) requiring cardiac catheterization to diagnose or treat the disease will be eligible for study.
Key inclusion criteria (8 listed)
- The subject is male or female;
- The subject is of any racial or ethnic group;
- The subject is between 0 days and 12 years of age;
- Is less than 40 kg;
- The subject is scheduled for a cardiac catheterization for treatment or diagnosis of a cardiovascular disease;
Key exclusion criteria (11 listed)
- Is greater than twelve (12) years of age;
- Has pre-existing allergies to adhesive tapes or adhesives on neonatal ECG pads;
- Has pre-existing skin condition at the site where the Nonin cerebral oximeter sensor will be placed (e.g., eczema, dermatitis);
- Has craniofacial disease preventing application of the sensor to the forehead;
- Has sickle cell anemia or other hemoglobinopathy;
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 |
|---|---|---|
| Model 7600 Regional Oximeter SystemNon-invasive regional oxygen saturation measurements | Device | Cohort Phase 1 |
Primary outcome
The success of the validation and calibration will be assessed through the Arms statistic.
Time frame: Single visit
1 secondary outcome
Tissue (somatic) sensor readings will be described using the descriptive statistics.
Time frame: Single Visit
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 25 Aug 2011.
- Derived from this study: PubMed 22858270Kreeger RN, Ramamoorthy C, Nicolson SC, Ames WA, Hirsch R, Peng LF, Glatz AC, Hill KD, Hoffman J, Tomasson J, Kurth CD. Evaluation of pediatric near-infrared cerebral oximeter for cardiac disease. Ann Thorac Surg. 2012 Nov;94(5):1527-33. doi: 10.1016/j.athoracsur.2012.05.096. Epub 2012 Aug 2.
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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.
Lori M Mitchell, RN, BSN study director
Nonin Medical, Inc
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by Nonin Medical, Inc at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. 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 25 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The success of the validation and calibration will be assessed through the Arms statistic. (time frame: Single visit). 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 NCT00939224, 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 25 Aug 2011.