Cardiac CatheterizationNCT00849940
Validation of Brain Oxygenation Monitor on Pediatric Patients
A study testing CAS NIRS FORE-SIGHT oximeter in people with Cardiac Catheterization, run by Duke University at 1 site in United States.
Trial summary
The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal organs (StO2). This is a measure of the amount of oxygen carried by the blood within the internal organs. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Cardiac Catheterization
- What is being tested?
- CAS NIRS FORE-SIGHT oximeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Nov 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ≤ 18 years old
- ≥ 2.5 kg and ≤ 40 kg weight
- Undergoing cardiac catheterization at Duke pediatric cardiac catheterization laboratory
Who cannot join
- Known structural neurologic or craniofacial disease
- Arterial catheter placement not part of planned catheterization procedure
- Anemia (hemoglobin < 10 g/dl)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health System
Durham, North Carolina, 27710
About this study
Official title: Validation of the CAS Medical System, Inc. FORE-SIGHT Near-Infrared Spectroscopy (NIRS) Monitor in Pediatric Subjects for Viscerosomatic Applications
The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal organs (StO2). This is a measure of the amount of oxygen carried by the blood within the internal organs. In addition the study will assess the degree of similarities between StO2 and mean mixed venous oxygen saturation - a measure of the amount of oxygen carried in the blood returning to the heart.
Read the detailed description
NIRS cerebral oximeters are FDA-approved devices used to measure oxygen saturation within the brain, in a similar manner to pulse oximeters that measure the oxygen saturation in the finger tip. The sensor pads are placed on the surface of the forehead and shine near-infrared light through the skull and brain tissue from which the brain tissue oxygen saturation is estimated. The same principles can be applied when the sensor pads are placed over the internal organs of the abdomen, for example, the liver. Currently the only way to accurately measure the oxygen saturation of internal organs is by the invasive placement of intravenous lines into the blood vessels of that organ. This study will determine if the NIRS sensors can reliably estimate the tissue oxygen saturation non-invasively by placing the pad over the skin of the abdomen.
The study will be conducted in pediatric patients who are undergoing cardiac catheterization, a procedure in which invasive lines are placed in order to get information about the heart. The procedure is always conducted under general anesthesia. During the cardiac catheterization procedure blood samples are routinely taken for oxygen saturation analysis. In the study two oximeter sensor pads will be placed on the forehead (one on each side) and two further oximeter sensor pads will be placed on the abdominal wall. The oxygen saturation values from all oximeter sensors will be recorded continuously throughout the cardiac catheterization procedure and will be compared to the oxygen saturation values from the blood samples. In addition to the routine blood samples taken as part of the cardiac catheterization, one blood sample will be taken when the invasive line is within the right hepatic (liver) vein.
The information from this study will determine how well the oximeter sensors estimate the oxygen saturation of both the internal organs (StO2) and the blood returning to the heart (mean mixed venous oxygen saturation).
- Conditions
- Cardiac Catheterization
- Being tested
- CAS NIRS FORE-SIGHT oximeter
- Keywords
- Spectroscopy, Near infrared, Oximetry, Hypoxemia, Tissue oxygenation, Pediatric
- Medical subject headings
- Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAS NIRS FORE-SIGHT oximeterDevice
Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
| Study group | Role | What they receive |
|---|---|---|
| CAS NIRS FORE-SIGHT oximeter | Experimental | Pediatric patients presenting for cardiac catheterization. Receives: Device: CAS NIRS FORE-SIGHT oximeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation
The flank tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of flank tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the flank tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.
oxygen saturation when measured displayed NIRS value of the tissue sensor placed over the flank to a reference CO-oximetry model, reported as bias and precision. The model is weighted as 30:70 arterial: central venous oxygen saturation when measured by blood gas co-oximetry.
Measured: Data collected from individual participants over 4 hour timeframe.
Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation
The intestine tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of intestine tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the intestine tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.
Measured: Data collected from individual participants over 4 hour timeframe.
Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation
The hepatic tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of hepatic tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the hepatic tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.
Measured: Data collected from individual participants over 4 hour timeframe.
Secondary outcomes (2)
Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation
Measured: Data collected from individual participants over 4 hour timeframe
Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.
Measured: Data collected from individual participants over 4 hour timeframe
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- CAS Medical Systems, Inc.
- Responsible party
- Sponsor
- Investigators
- David B MacLeod, FCRA, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849940
- Sponsor's protocol ID
- Pro00009391
- Status last verified
- Feb 2016
- First submitted
- 22 Jan 2009
- Last updated
- 9 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the CAS Medical System, Inc. FORE-SIGHT Near-Infrared Spectroscopy (NIRS) Monitor in Pediatric Subjects for Viscerosomatic Applications
- ClinicalTrials.gov ID
- NCT00849940
- Acronym / sponsor ID
- Pro00009391
- Conditions
- Cardiac Catheterization
- Keywords
- Spectroscopy, Near infrared, Oximetry, Hypoxemia, Tissue oxygenation, Pediatric
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- CAS Medical Systems, Inc.
- Study start
- Feb 2009
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Posted 28 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is calibrate (adjust and tune) the CAS FORE-SIGHT Near-Infrared Spectroscopy (NIRS) monitor when used to measure the tissue oxygen saturation of internal organs (StO2). This is a measure of the amount of oxygen carried by the blood within the internal organs. In addition the study will assess the degree of similarities between StO2 and mean mixed venous oxygen saturation - a measure of the amount of oxygen carried in the blood returning to the heart.
Detailed description
NIRS cerebral oximeters are FDA-approved devices used to measure oxygen saturation within the brain, in a similar manner to pulse oximeters that measure the oxygen saturation in the finger tip. The sensor pads are placed on the surface of the forehead and shine near-infrared light through the skull and brain tissue from which the brain tissue oxygen saturation is estimated. The same principles can be applied when the sensor pads are placed over the internal organs of the abdomen, for example, the liver. Currently the only way to accurately measure the oxygen saturation of internal organs is by the invasive placement of intravenous lines into the blood vessels of that organ. This study will determine if the NIRS sensors can reliably estimate the tissue oxygen saturation non-invasively by placing the pad over the skin of the abdomen.
The study will be conducted in pediatric patients who are undergoing cardiac catheterization, a procedure in which invasive lines are placed in order to get information about the heart. The procedure is always conducted under general anesthesia. During the cardiac catheterization procedure blood samples are routinely taken for oxygen saturation analysis. In the study two oximeter sensor pads will be placed on the forehead (one on each side) and two further oximeter sensor pads will be placed on the abdominal wall. The oxygen saturation values from all oximeter sensors will be recorded continuously throughout the cardiac catheterization procedure and will be compared to the oxygen saturation values from the blood samples. In addition to the routine blood samples taken as part of the cardiac catheterization, one blood sample will be taken when the invasive line is within the right hepatic (liver) vein.
The information from this study will determine how well the oximeter sensors estimate the oxygen saturation of both the internal organs (StO2) and the blood returning to the heart (mean mixed venous oxygen saturation).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAS NIRS FORE-SIGHT oximeter | Experimental | Device: CAS NIRS FORE-SIGHT oximeterPediatric patients presenting for cardiac catheterization. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ≤ 18 years old
- ≥ 2.5 kg and ≤ 40 kg weight
- Undergoing cardiac catheterization at Duke pediatric cardiac catheterization laboratory
Key exclusion criteria (3 listed)
- Known structural neurologic or craniofacial disease
- Arterial catheter placement not part of planned catheterization procedure
- Anemia (hemoglobin < 10 g/dl)
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 |
|---|---|---|
| CAS NIRS FORE-SIGHT oximeterComparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation. | Device | CAS NIRS FORE-SIGHT oximeter |
Primary outcome
Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation
Time frame: Data collected from individual participants over 4 hour timeframe.
The flank tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of flank tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the flank tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other. oxygen saturation when measured displayed NIRS value of the tissue sensor placed over the flank to a reference CO-oximetry model, reported as bias and precision. The model is weighted as 30:70 arterial: central venous oxygen saturation when measured by blood gas co-oximetry.
Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation
Time frame: Data collected from individual participants over 4 hour timeframe.
The intestine tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of intestine tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the intestine tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.
Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation
Time frame: Data collected from individual participants over 4 hour timeframe.
The hepatic tissue oxygen saturation (%) is determined from simultaneous arterial and venous blood samples processed through a blood gas machine. The blood oxygen saturation of the samples are entered into an equation to yield the best estimate of hepatic tissue oxygen saturation. This value is then compared to the NIRS oxygen saturation (%) displayed on the monitor. Accuracy is used to describe how close the NIRS oxygen saturation is to the hepatic tissue oxygen saturation. It can be expressed in terms of shots on target: bias (%) = how close are the shots to the bulls eye and precision (%) is how close are the shots to each other.
2 secondary outcomes
Correlation Between Somatic StO2 and Cerebral SctO2 Oxygen Saturation
Time frame: Data collected from individual participants over 4 hour timeframe
Correlation Between NIRS Derived Estimate of Hemoglobin Concentration and Measured Arterial Blood Hemoglobin Concentration.
Time frame: Data collected from individual participants over 4 hour timeframe
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David B MacLeod, FCRA principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAS NIRS FORE-SIGHT oximeter in people with Cardiac Catheterization, run by Duke University at 1 site 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Feb 2017. 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 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?
Yes. Results are posted in the registry (first posted 28 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 NIRS Sensor to Estimate Flank Tissue Oxygen Saturation (time frame: Data collected from individual participants over 4 hour timeframe.). The study lists 3 primary outcomes in all. 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 Feb 2017.