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NCT03869606 · ClinicalTrials.gov registry record

Non-Invasive Cardiac Output Monitor in Children

A clinical trial, sponsored by Indiana University.

Completed
Registry status
50
Enrollment target

NCT03869606: Completed study, sponsored by Indiana University.

NCT03869606 is a clinical trial that has completed, run by Indiana University. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03869606 has completed, sponsored by Indiana University.

COMPLETED
Registry status
50 participants
Enrollment target

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.

Primary Outcome

Stroke volume x Heart Rate = Cardiac Output

Interventions

  • DEVICE NICOM by Cheetah Medical

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2019-04-01
Est. Completion 2020-04-01
Indiana University

890 total trials

What the finished NCT03869606 record still lists

NCT03869606 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which NICOM by Cheetah Medical is the first listed.

NCT03869606 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03869606 about?

NCT03869606 is a clinical study titled "Non-Invasive Cardiac Output Monitor in Children". 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 befor...

What is the current status of trial NCT03869606?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2019-04-01. Estimated completion is 2020-04-01.

What interventions are being tested in trial NCT03869606?

The interventions under investigation include: NICOM by Cheetah Medical (DEVICE).

Who is sponsoring clinical trial NCT03869606?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03869606, the US trial registry maintained by the National Library of Medicine. NCT03869606 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.