Plethysmography as a Useful Intraoperative Monitor

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT01843244
• Lead Sponsor: University of Virginia

Brief Summary

Data from both the traditional invasive cardiac monitors and the Nonin will be collected simultaneously. The investigators will analyze Nonin data for peak and trough variation with respiration, area under the curve, time from trough to peak, and slope, and compare these to data collected from the invasive monitors to look for correlations in clinically important parameters such as blood pressure, central venous pressure, cardiac output, etc.

Detailed Description

After obtaining written consent to participate, the standard of care arterial line and PA catheter will be placed pre-operatively. The investigators will attach the Nonin pulse oximeter, as a second pulse oximeter probe, to patients undergoing surgical procedures which already require invasive cardiac monitors (arterial line, pulmonary artery catheter, etc). Data from both the traditional invasive cardiac monitors and the Nonin pulse oximeter will be collected as electronic files. Once both files are compiled they will be de-identified.

The investigators will also record medications and IV fluids given during surgery.

The Nonin Pulse Oximeter is clinically marketed for this indication

The investigators will analyze Nonin data for peak and trough variation with respiration, area under the curve, time from trough to peak, and slope, and compare these to data collected from the invasive monitors to look for correlations in clinically important parameters such as blood pressure, central venous pressure, cardiac output, etc.

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Study First Submitted: 2011-08-09
• Status Verified: 2013-04
• Study First Submitted QC: 2013-04-29
• Last Update Submitted: 2013-04-29
• Study First Posted: 2013-04-30
• Last Update Posted: 2013-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• 18 years of age and older Patient scheduled for surgery that will have both an arterial catheter and a pulmonary artery catheter as standard of care Informed consent

Exclusion Criteria

• Only the above inclusion criteria apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
waveform variation of the Nonin pulse oximeter compared with that of the arterial catheter	during surgery	The investigators will analyze Nonin data for peak and trough variation with respiration, area under the curve, time from trough to peak, and slope, and compare these to data collected from the invasive monitors to look for correlations in clinically important parameters such as blood pressure, central venous pressure, cardiac output, etc.

Trial Locations

Locations (1)

University of Virginia Health System; 🇺🇸 Charlottesville, Virginia, United States