Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors

This study has been completed.
Sponsor:
Collaborator:
Covidien
Information provided by:
Children's Research Institute
ClinicalTrials.gov Identifier:
NCT00843401
First received: February 12, 2009
Last updated: February 1, 2011
Last verified: February 2011
  Purpose

The general purpose of this study is to evaluate the feasibility, accuracy and performance of the Nellcor/Covidian 600-x and the Masimo rainbow technologypediatric and neonatal oximetry sensors over clinically relevant ranges of arterial saturations between 60-100%.

The study objectives are as follows:

  1. To evaluate the accuracy of a neonatal sensor in the saturation range of 70-80% in the following weight category: 0-5kg.
  2. To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 60-80% in the following weight categories: 0-5kg; and, 5-40kg.
  3. To evaluate the accuracy of neonatal and pediatric transmission (digit/foot/hand) sensors in the saturation range of 80-100% in the following weight ranges: 0-5kg; and, 5-40kg.

Condition
Low Oxygen Saturation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors

Resource links provided by NLM:


Further study details as provided by Children's Research Institute:

Estimated Enrollment: 100
Study Start Date: January 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pediatric intensive care unit Pediatric Cardiac Intensive Care Unit

Criteria

Inclusion Criteria:

  • Signed Informed Consent (If the patient is a minor, signed parental consent will be obtained.)
  • Anticipated need for pulse oximetry monitoring
  • Arterial line in place as indicated per patient's clinical management needs
  • Availability to analyze arterial blood saturation by Co-Oximeter or Blood Gas Analyzer

Exclusion Criteria:

  • Inability to provide informed consent (or parental consent)
  • Known allergies to adhesive materials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843401

Locations
United States, District of Columbia
Childrens Research Institute
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Children's Research Institute
Covidien
  More Information

No publications provided

Responsible Party: Karen B Woronick Clinical research Coordinator Critical Care, Children's National Medical Center
ClinicalTrials.gov Identifier: NCT00843401     History of Changes
Other Study ID Numbers: 110404, Rev. C
Study First Received: February 12, 2009
Last Updated: February 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Research Institute:
Low oxygen saturation
Anticipated need for pulse oximetry monitoring
Arterial line in place as indicated per patient's clinical management needs
Availability to analyze arterial blood saturation by Co-Oximeter or
Blood Gas Analyzer

ClinicalTrials.gov processed this record on July 26, 2014