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

This study has been terminated.
(Terminated due to software issues.)
Sponsor:
Collaborator:
Covidien
Information provided by:
Saint Luke's Health System
ClinicalTrials.gov Identifier:
NCT01128036
First received: May 20, 2010
Last updated: August 8, 2011
Last verified: August 2011

May 20, 2010
August 8, 2011
May 2010
May 2011   (final data collection date for primary outcome measure)
Signal quality loss (dropout rate) [ Time Frame: Every 2 seconds for one hour ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01128036 on ClinicalTrials.gov Archive Site
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Not Provided
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Comparison of Different Locations for Pulse Oximetry Probes in Cardiovascular (CV) Patients With Poor Peripheral Perfusion
Comparison of Different Locations for Pulse Oximetry Probes in Adult Cardiovascular Patients With Poor Peripheral Perfusion

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients admitted to the CICU (Coronary Intensive Coronary Unit) with congestive heart failure or cardiomyopathy

  • Congestive Heart Failure
  • Cardiomyopathy
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CHF, cardomyopathy
Patients with signs of poor peripheral perfusion due to cardiomyopathy or congestive heart failure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01128036
COVMOPO0054
No
Marci Sportsman, Saint Luke's Hospital
Saint Luke's Health System
Covidien
Study Director: Lisa Riggs, MSN Saint Luke's Hospital
Principal Investigator: Marci Sportsman, BSN Saint Luke's Hospital
Saint Luke's Health System
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP