NCT00939224

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 25, 2011

Status Verified

August 1, 2011

Enrollment Period

2.1 years

First QC Date

July 10, 2009

Last Update Submit

August 23, 2011

Conditions

Cardiovascular Disease

Keywords

Near-infrared spectroscopy (NIRS)Regional oxygen saturationPediatricsCardiac catheterizationCongenital heart disease

Outcome Measures

Primary Outcomes (1)

  • The success of the validation and calibration will be assessed through the Arms statistic.

    Single visit

Secondary Outcomes (1)

  • Tissue (somatic) sensor readings will be described using the descriptive statistics.

    Single Visit

Study Arms (1)

Cohort Phase 1

Cardiac Catheterization

Device: Model 7600 Regional Oximeter System

Interventions

Model 7600 Regional Oximeter SystemDEVICE

Non-invasive regional oxygen saturation measurements

Cohort Phase 1

Eligibility Criteria

AgeUp to 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Stanford University School of Medicine

Stanford, California, 94305-5640, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Cincinnati Children Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

  • 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.

    PMID: 22858270DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesHeart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Lori M Mitchell, RN, BSN

    Nonin Medical, Inc

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 25, 2011

Record last verified: 2011-08

Locations

US(3)