Study of Non-Invasive Regional Oxygen Saturations in Pediatric Patients Undergoing Cardiac Catheterization

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease
• Intervention / Treatment: Device: Model 7600 Regional Oximeter System

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305-5640
      • Stanford University School of Medicine
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort Phase 1; Cardiac Catheterization	Device: Model 7600 Regional Oximeter System; Non-invasive regional oxygen saturation measurements

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The success of the validation and calibration will be assessed through the Arms statistic.	Single visit

Secondary Outcome Measures

Outcome Measure	Time Frame
Tissue (somatic) sensor readings will be described using the descriptive statistics.	Single Visit

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc
• Investigators: Study Director: Lori M Mitchell, RN, BSN, Nonin Medical, Inc

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: July 10, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 14, 2009

Study Record Updates

• Last Update Posted (Estimate): August 25, 2011
• Last Update Submitted That Met QC Criteria: August 23, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Pediatrics; Congenital heart disease; Cardiac catheterization; Near-infrared spectroscopy (NIRS); Regional oxygen saturation
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: QATP1542