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
  Purpose

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
Congestive Heart Failure
Cardiomyopathy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Saint Luke's Health System:

Primary Outcome Measures:
  • Signal quality loss (dropout rate) [ Time Frame: Every 2 seconds for one hour ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: May 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
CHF, cardomyopathy
Patients with signs of poor peripheral perfusion due to cardiomyopathy or congestive heart failure

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  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: NCT01128036

Locations
United States, Missouri
Saint Luke's Hospital
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
Saint Luke's Health System
Covidien
Investigators
Study Director: Lisa Riggs, MSN Saint Luke's Hospital
Principal Investigator: Marci Sportsman, BSN Saint Luke's Hospital
  More Information

No publications provided

Responsible Party: Marci Sportsman, Saint Luke's Hospital
ClinicalTrials.gov Identifier: NCT01128036     History of Changes
Other Study ID Numbers: COVMOPO0054
Study First Received: May 20, 2010
Last Updated: August 8, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014