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OpenTrials
Completed

NCT Number: NCT01843244

Plethysmography as a Useful Intraoperative Monitor

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. waveform variation of the Nonin pulse oximeter compared with that of the arterial catheter

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 30, 2013
Registry last updated
Apr 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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