Cerebral OxygenationINCATHNCT05962905
Accuracy Performance Verification of the INVOS™ System in Pediatrics
An observational study of Cerebral Oxygenation and Pediatric ALL, run by Medtronic - MITG at 5 sites in United States.
Trial summary
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system. Read more about this study
- Who is it for?
- Ages 0 to 21 years
- Conditions the study is for
- Cerebral Oxygenation, Pediatric ALL
- What is being tested?
- Blood sample and INVOS monitoring
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Nov 2023to 30 Apr 2025
- 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 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients (under 21) weighing under 40 kg scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
Who may be able to join
- Under 21 years of age
- Meets weight requirement for sensors under study
- Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
- Arterial and venous access as part of the planned catheterization procedure
Who cannot join
- Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
- A skin condition at the sensor site (e.g., rash, abrasion, laceration)
- Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor
- A known structural brain lesion beneath the sensor
- Known hemoglobinopathy
- Inability to lie supine with neutral neck position during catheterization
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- Cerebrovascular disease
- An emergent, life threatening condition impacting study conduct
- Unwillingness or inability to sign informed consent (IC) or assent by the parents/guardians of child
- Currently receiving phototherapy for bilirubin
- Arterial or venous anatomy that would preclude obtaining an accurate paired sample
- Known pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cleveland Clinic Children's
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27710
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Seattle Children's
Seattle, Washington, 98105
Washington University St. Louis
St Louis, Missouri, 63110
About this study
Official title: Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
Read the detailed description
The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients bycomparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained throughinternal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.
- Conditions
- Cerebral Oxygenation, Pediatric ALL
- Being tested
- Blood sample, INVOS monitoring
- Keywords
- cerebral oximetry, pediatric, infant
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
During the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization
INVOS monitoringDevice
During the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric | Subjects meeting inclusion criteria weighing between 4 and 40 kg Receives: Other: Blood sample; Device: INVOS monitoring | |
| Infant | Subjects meeting inclusion criteria weighing under 40 kg Receives: Other: Blood sample; Device: INVOS monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the root mean square
root mean square of the difference in regional oxygen saturation (rSO2) as measured by the INVOS and field saturation (fSO2) as measured by blood sampling
Measured: At the point of blood sampling during cardiac catheterization procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start16 Nov 2023
- Primary completion30 Nov 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral OxygenationStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ami R Stuart, PhD, Study director, Principal Clinical Research Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962905
- Sponsor's protocol ID
- MDT23002INCATH
- Acronym
- INCATH
- Status last verified
- May 2025
- First submitted
- 13 Jul 2023
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medtronic Accuracy Performance Verification of the INVOS™ System in the Pediatric Cardiac Catheterization Laboratory (INCATH)
- ClinicalTrials.gov ID
- NCT05962905
- Acronym / sponsor ID
- INCATH / MDT23002INCATH
- Conditions
- Cerebral Oxygenation, Pediatric ALL
- Keywords
- cerebral oximetry, pediatric, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 27 Jul 2023 (actual)
- 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.
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
Detailed description
The purpose of this study is to verify INVOS™ cerebral oximetry system performance in pediatric and infant patients bycomparing regional oxygen saturation (rSO2) values to reference blood oxygen saturation measurements obtained throughinternal jugular vein and arterial blood convenience sampling according to International Organization on Standards (ISO) 80601-2-85:2021.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric | – | Other: Blood sample, Device: INVOS monitoringSubjects meeting inclusion criteria weighing between 4 and 40 kg |
| Infant | – | Other: Blood sample, Device: INVOS monitoringSubjects meeting inclusion criteria weighing under 40 kg |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients (under 21) weighing under 40 kg scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
Key inclusion criteria (4 listed)
- Under 21 years of age
- Meets weight requirement for sensors under study
- Scheduled for a diagnostic or interventional cardiac catheterization procedure with general anesthesia or sedation
- Arterial and venous access as part of the planned catheterization procedure
Key exclusion criteria (12 listed)
- Prior known severe allergies to medical grade adhesive/tape (Band-Aid) [self-reported]
- A skin condition at the sensor site (e.g., rash, abrasion, laceration)
- Craniofacial disease producing abnormal forehead anatomy and/or preventing forehead application of the sensor
- A known structural brain lesion beneath the sensor
- Known 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 |
|---|---|---|
| Blood sampleDuring the standard of care interventional or diagnostic cardiac catheterization, paired arterial and venous blood samples will be obtained. The venous sample will be obtained from 2 cm superior to the clavicle, which is beyond standard of care during the routine cardiac catheterization | Other | Infant, Pediatric |
| INVOS monitoringDuring the standard of care interventional or diagnostic cardiac catheterization, INVOS monitoring will be used. INVOS™ regional oxygen saturation (rSO2) values will be compared to the calculated global field saturation of cerebral tissue determined from blood sample co-oximetry. | Device | Infant, Pediatric |
Primary outcome
Accuracy of the root mean square
Time frame: At the point of blood sampling during cardiac catheterization procedure
root mean square of the difference in regional oxygen saturation (rSO2) as measured by the INVOS and field saturation (fSO2) as measured by blood sampling
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 9 May 2025.
- Individual participant dataSharing planned: No
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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.
Ami R Stuart, PhD study director
Principal Clinical Research Specialist
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Oxygenation and Pediatric ALL, run by Medtronic - MITG at 5 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 4 inclusion and 12 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 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Accuracy of the root mean square (time frame: At the point of blood sampling during cardiac catheterization procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2025.