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

Congestive Heart Failure Clinical Trial

Official title:

Comparison of Different Locations for Pulse Oximetry Probes in Adult Cardiovascular Patients With Poor Peripheral Perfusion

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01128036
• Other study ID #: COVMOPO0054
• Status: Terminated
• Phase: N/A
• First received: May 20, 2010
• Last updated: August 8, 2011
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: August 2011
• Source: Saint Luke's Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 51
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	Saint Luke's Hospital	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Saint Luke's Health System	Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Signal quality loss (dropout rate)		Every 2 seconds for one hour	No