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A Prospective Study of a New Non-Invasive Cardiac Output Monitor in Children Undergoing General Anesthesia

NCT01499615 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 402

Last updated 2015-04-09

No results posted yet for this study

Summary

Traditionally cardiac output has been estimated with thermodilution. Recently a new non-invasive device has been approved by the FDA for use in children of all ages including neonates (just 4 EKG electrodes). Primary outcome: To prospectively collect simultaneous physiologic data for all enrolled children by transferring the data from the investigators computerized anesthesia records to Excel spreadsheets and to correlate adverse events across monitoring devices.

Secondary outcomes: To determine if the device provides meaningful data in terms of an early warning of decreased cardiac output in specific subgroups of children undergoing surgery and anesthesia, e.g., neonates, trauma patients, children with congenital heart disease, those undergoing procedures with expected blood loss, those undergoing laparoscopic procedures where gas insufflation may impede venous return to the heart.

Conditions

  • Children Receiving General Anesthesia

Interventions

DEVICE

cardiac monitor

All children receive the same intervention which is the application of the 4 ekg electrodes

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Eligibility

Min Age
1 Hour
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2014-01-31
Completion
2014-01-31

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 NCT01499615 on ClinicalTrials.gov