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Non-Invasive Cardiac Output Monitor in Children

NCT03869606 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2020-07-30

No results posted yet for this study

Summary

This study will be the first of several studies that establish the value of measuring fluid responsiveness in children undergoing general anesthesia. The first study in this series will determine whether fluid responsiveness, as measured with the NICOM cardiac output monitor in normal children before and after passive leg raising, predicts changes in stroke volume, cardiac output, and blood pressure during the early stages of anesthesia. A second study will determine if early treatment of the fluid responsiveness will prevent the decline in blood pressure that accompanies general anesthesia. If the NICOM monitor permits accurate prediction in normal patients, future studies of pediatric patients undergoing major surgery would be indicated.

The investigators would like to add 25 additional patients who will have the NICOM assessments performed in the pre operative area - Pre anesthesia. General anesthesia may alter the results of the NICOM assessments. The investigators will use these 25 subjects to serve as a comparison/control group.

Conditions

  • Cardiac Output, Low
  • Pediatric

Interventions

DEVICE

NICOM by Cheetah Medical

Observational measurement, Cardiac Output, Pre- and Post Anesthesia

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Andrew F Stasic, MD · Indiana University School of Medicine

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2020-04-01
Completion
2020-04-01
FDA Device
Yes

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 NCT03869606 on ClinicalTrials.gov