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A Prospective Study to Bilaterally Compare a Non-Invasive Cardiac Output Monitor

NCT01678066 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2012-09-03

No results posted yet for this study

Summary

Study hypothesis: The Cardiotronic ICON non-invasive cardiac output monitor gives accurate information when placed on a patient's Right or Left side.

Summary: To simultaneously compare physiologic data collected from two non-invasive cardiac output monitors placed bilaterally on pediatric patients undergoing general anesthesia. The FDA approved Cardiotronic ICON non-invasive cardiac output monitor has been validated by the manufacturer in pediatric and adult patients with leads placed on the left side. However, sometimes the surgical site and/or patient position precludes placement of the monitor leads on the left side. In such situations it would be useful to know whether placement of the monitor's leads on a patient's right side gives accurate cardiac output data. We will prospectively collect, and compare, simultaneous physiologic data for all enrolled children using two monitors, one on the patient's right side and one on the patient's left side.

Conditions

  • Anesthesiology
  • Pediatrics
  • General Surgery
  • Orthopedics
  • General Anesthesia
  • Cardiac Output

Interventions

DEVICE

Bilateral cardiac output

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Thomas A Anderson, PhD, MD · Massachusetts General Hospital

Eligibility

Min Age
1 Month
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-30
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01678066 on ClinicalTrials.gov