MedTrace Logo

Clinical Performance Evaluation of Pediatric and Neonatal Low Saturation Oximetry Sensors

NCT00843401 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2011-02-02

No results posted yet for this study

Summary

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.

Conditions

  • Low Oxygen Saturation

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Children's National Research Institute

    lead OTHER

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00843401 on ClinicalTrials.gov