NCT01843244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2011

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

10 months

First QC Date

August 9, 2011

Last Update Submit

April 29, 2013

Conditions

Cardiovascular Diseases

Keywords

plethysmography

Outcome Measures

Primary Outcomes (1)

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

    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.

    during surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient scheduled for surgery that will have both an arterial catheter and a pulmonary artery catheter as standard of care

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Robert Thiele, MD

    UVA Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2011

First Posted

April 30, 2013

Study Start

July 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

US(1)