Trial Outcomes & Findings for Validation of Brain Oxygenation Monitor on Pediatric Patients (NCT NCT00849940)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

72 participants

Primary outcome timeframe

Data collected from individual participants over 4 hour timeframe.

Results posted on

2017-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	CAS NIRS FORE-SIGHT Oximeter Pediatric patients presenting for cardiac catheterization. CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
Overall Study STARTED	72
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	CAS NIRS FORE-SIGHT Oximeter Pediatric patients presenting for cardiac catheterization. CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
Overall Study Physician Decision	4

Baseline Characteristics

Validation of Brain Oxygenation Monitor on Pediatric Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAS NIRS FORE-SIGHT Oximeter n=72 Participants Pediatric patients presenting for cardiac catheterization. CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
Age, Categorical <=18 years	72 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	34 Participants n=5 Participants
Gender Male	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	66 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants

PRIMARY outcome

Timeframe: Data collected from individual participants over 4 hour timeframe.

Population: Weight range 3.9 - 49.5 kg; age 0.2 - 12.3 years represent the values of the participants analyzed.

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.

Outcome measures

Outcome measures
Measure	CAS NIRS FORE-SIGHT Oximeter n=43 Participants Pediatric patients presenting for cardiac catheterization. CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
Accuracy of NIRS Sensor to Estimate Flank Tissue Oxygen Saturation	-0.67 percentage of oxygen saturation Standard Deviation 4.88

PRIMARY outcome

Timeframe: Data collected from individual participants over 4 hour timeframe.

Population: Weight 2.9 - 24.0 kg; age 0.04 - 9.8 years represent the values of the participants analyzed.

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.

Outcome measures

Outcome measures
Measure	CAS NIRS FORE-SIGHT Oximeter n=45 Participants Pediatric patients presenting for cardiac catheterization. CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
Accuracy of NIRS Sensor to Estimate Intestine Tissue Oxygen Saturation	1.57 percentage of oxygen saturation Standard Deviation 4.41

PRIMARY outcome

Timeframe: Data collected from individual participants over 4 hour timeframe.

Population: Weight 2.9 - 25.4 kg; age 0.04 - 10.2 years represent the values of the participants analyzed.

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.

Outcome measures

Outcome measures
Measure	CAS NIRS FORE-SIGHT Oximeter n=63 Participants Pediatric patients presenting for cardiac catheterization. CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation.
Accuracy of NIRS Sensor to Estimate Hepatic Tissue Oxygen Saturation	0.04 percentage of oxygen saturation Standard Deviation 5.63

SECONDARY outcome

Timeframe: Data collected from individual participants over 4 hour timeframe

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Data collected from individual participants over 4 hour timeframe

Population: Data not collected.

Outcome measures

Outcome data not reported

Adverse Events

CAS NIRS FORE-SIGHT Oximeter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David MacLeod, M.B.

Duke University Medical Center

Phone: 919-681-3551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place