Comparison of Different Locations for Pulse Oximetry Probes in Cardiovascular (CV) Patients With Poor Peripheral Perfusion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01128036
Recruitment Status : Terminated (Terminated due to software issues.)
First Posted : May 21, 2010
Last Update Posted : August 9, 2011
Medtronic - MITG
Information provided by:
Saint Luke's Health System

Brief Summary:
The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality.

Condition or disease
Congestive Heart Failure Cardiomyopathy

Detailed Description:
A comparison study design will be used to evaluate the signal quality of pulse oximetry sensors placed in two locations: forehand and finger. Each subject will serve as their own control, with measurements of signal quality evaluated at 2 second intervals over a period of one hour. The measurements will be recorded simultaneously with a computer program and laptop computer. Finger and forehand sensors will be applied according to manufacturer's guidelines. An output connection will be made from each pulse oximeter computer unit to a password protected, laptop computer for data downloading. Data will be collected for a 1 hour period at 2 second increments and stored in the hard drive of the laptop. Following completion of data collection, the study sensors will be removed.

Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Different Locations for Pulse Oximetry Probes in Adult Cardiovascular Patients With Poor Peripheral Perfusion
Study Start Date : May 2010
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

CHF, cardomyopathy
Patients with signs of poor peripheral perfusion due to cardiomyopathy or congestive heart failure

Primary Outcome Measures :
  1. Signal quality loss (dropout rate) [ Time Frame: Every 2 seconds for one hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the CICU (Coronary Intensive Coronary Unit) with congestive heart failure or cardiomyopathy

Inclusion Criteria:

  • CICU patients with a new diagnosis or history of CHF or cardiomyopathy
  • Patients with a medical order for pulse oximetry monitoring
  • Age greater than or equal to 18 years of age
  • English speaking
  • Signs of hypoperfusion

Exclusion Criteria:

  • CICU patients with an impediment to sensor application
  • CICU patients with excessive facial edema
  • CICU patients with mechanical ventilation
  • CICU patients with intra-aortic balloon pump therapy
  • CICU patients with intravenous vasopressor drug administration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01128036

United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Saint Luke's Health System
Medtronic - MITG
Study Director: Lisa Riggs, MSN Saint Luke's Hospital
Principal Investigator: Marci Sportsman, BSN Saint Luke's Hospital

Responsible Party: Marci Sportsman, Saint Luke's Hospital Identifier: NCT01128036     History of Changes
Other Study ID Numbers: COVMOPO0054
First Posted: May 21, 2010    Key Record Dates
Last Update Posted: August 9, 2011
Last Verified: August 2011

Keywords provided by Saint Luke's Health System:
Congestive Heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases