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Trial record 17 of 629 for:    oximeter

Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease

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ClinicalTrials.gov Identifier: NCT02237014
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : March 8, 2017
Sponsor:
Information provided by (Responsible Party):
Chandra Ramamoorthy, Stanford University

Tracking Information
First Submitted Date November 9, 2012
First Posted Date September 11, 2014
Last Update Posted Date March 8, 2017
Study Start Date November 2012
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 10, 2014)
Accuracy of Peripheral Pulse Oximetry versus Arterial Co-oximeter in Children with Cyanotic Heart Disease [ Time Frame: 2 year ]
The primary outcome measure is to describe the bias and precision between the Masimo blue sensor and co-oximetry.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02237014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 10, 2014)
establish correct limits of peripheral pulse oximeter when using the standard and the study sensors. [ Time Frame: 2year ]
The secondary measure was to describe the limits of the blue sensor and standard sensor accuracy as compared with the co-oximeter. If the test sensors consistently have a bias greater than 2 SD from the co-oximeter value at saturations lower than eg., 80 then the recommendation would be that the co-oximetry be used to measure patients saturatioin rather than relying on pulse oximtery alone for clinical decision making
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease
Official Title Accuracy of Peripheral Pulse Oximetry Versus Arterial Co-oximeter in Children With Cyanotic Heart Disease
Brief Summary Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study the investigators will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.
Detailed Description

Peripheral pulse oximetry allows continuous non-invasive measurement of arterial oxygen saturation, but the gold standard for arterial oxygen saturation is co-oximeter which requires an arterial blood sample. The purpose of this research study is to determine the accuracy of a pulse oximeter with a standard sensor (Masimo LNCS sensor) versus with the study sensors, namely Masimo blue sensor and Nellcor Max-I sensors and compared against co-oximetry. Currently available peripheral oximeters (standard) are inaccurate at low oxygen saturation noted in children with cyanotic heart disease. Hence therapeutic interventions (including surgery and cardiac catheterizations) based solely on peripheral oximetry can be delayed and or inadequate. By doing this study we will be able to establish correct limits of peripheral pulse oximeter when using the standard and the study sensors.

The investigator hopes to learn the limits of accuracy of currently available and used pulse oximeters. In children with cyanotic heart disease the "blue sensor" has been found in small studies to be more accurate compared to the "standard" pulse oximeter.

This study is important as it will provide information as to which pulse oximeter should be routinely used in children with cyanotic heart disease and to assess which SPO2 even with blue sensor is borderline and therefore the physician will know to obtain arterial blood sample for co-oximeter prior to planning important procedures based on a saturation reading.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
whole blood
Sampling Method Non-Probability Sample
Study Population Children with cyanotic heart disease undergoing cardiac catheterization or heart surgery in Stanford University Medical Center(SUMC) or Lucile Packard Children's Hospital(LPCH) respectively with peripheral arterial saturation less than 90% at time of enrollment.
Condition Cyanotic Heart Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 4, 2016)
53
Original Estimated Enrollment
 (submitted: September 10, 2014)
100
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Children from LPCH undergoing cardiac catheterization or heart surgery in SUMC or LPCH respectively
  2. Peripheral arterial saturation less than or equal to 90% at time of enrollment
  3. weigh between 3-20 kg
  4. Less than or equal to 10 years of age

Exclusion Criteria:

  1. Lack of consent
  2. Greater than 10 years of age
  3. Less than 3 kg or more than 20 kg in weight
  4. Peripheral arterial saturation greater than 90% at time of enrollment
  5. Lack of arterial access
Sex/Gender
Sexes Eligible for Study: All
Ages up to 10 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02237014
Other Study ID Numbers SU-11062012-11219
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Yes
Responsible Party Chandra Ramamoorthy, Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Chandra Ramamoorthy, MD Department of Anesthesia, Stanford University School of Medicine
PRS Account Stanford University
Verification Date March 2017