Non-Invasive Cardiac Output Monitor in Children

NCT03869606 | Completed DMC FDA Device

• 1 other identifier: 1808715198
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cardiac Output via NICOM monitor

  Stroke volume x Heart Rate = Cardiac Output

  Pre-Induction and fifteen minutes up to thirty minutes Post-Anesthesia Induction

Interventions

NICOM by Cheetah Medical DEVICE

Observational measurement, Cardiac Output, Pre- and Post Anesthesia

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Healthy 10 to 17 years old

You may qualify if:

• Patients 11 to no older than 17 years of age

You may not qualify if:

• severed developmental delay,
• orthopedic patients with leg injuries
• injury that would prevent passive leg elevation.
• severe aortic insufficiency,
• severe anatomic abnormalities of the thoracic aorta
• patients with external cardiac pacemakers. close

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Cardiac Output, Low

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew F Stasic, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 11, 2019
• Study Start: April 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)