Clinical trial NCT00939224: Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization
Official title: Calibration and Validation of the a Non-Invasive Regional Oxygen Saturation Device in Neonates, Infants and Children Undergoing Cardiac Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: Near-infrared spectroscopy (NIRS)
Regional oxygen saturation
Pediatrics
Cardiac catheterization
Congenital heart disease
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 100
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: The success of the validation and calibration will be assessed through the Arms statistic.
timeFrame: Single visit
Secondary outcomes:
measure: Tissue (somatic) sensor readings will be described using the descriptive statistics.
timeFrame: Single Visit
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Cincinnati
country: United States
facility: Cincinnati Children Hospital Medical Center
state: Ohio
Study officials:
affiliation: Nonin Medical, Inc
name: Lori M Mitchell, RN, BSN
role: STUDY_DIRECTOR
References:
citation: 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.