Non-invasive Cardiac Output Monitor in Young Adults (NICOM)

A Trial of a Non-Invasive Cardiac Output in Young Adults

The investigators would like to study cardiac output, stroke volume, and fluid responsiveness on young adult pediatric patients undergoing anesthesia and surgery with the use of the NICOM, a non-invasive monitor. The NICOM method is non-invasive and provides reliable trending of cardiac output and stroke volume. Measuring cardiac output in conjunction with routine monitoring will provide a better assessment of intra-operative status.

Study Overview

• Status: Completed
• Conditions: Fluid Overload; Hypovolemia
• Intervention / Treatment: Device: NICOM

Detailed Description

This study will involve measurements of cardiac output, stroke volume, and fluid responsiveness (change in stroke volume of ≥ 10%) obtained via passive leg raise (PLR) before and after anesthesia induction.

• Study Type: Observational
• Enrollment (Actual): 50

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients 18-30 years of age having surgery at Riley or University Hospital

Description

Inclusion Criteria:

• 18 -30 years of age
• presenting for surgery at Riley or University Hospital

Exclusion Criteria:

• younger than 18
• severely mentally handicapped
• orthopedic cases with leg injuries
• any other contraindications that would prevent or discourage passive leg raises
• if deemed ineligible by an investigator for any other reason.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Use of Cheetah medical NICOM; For those who consent to the study, the Cheetah NICOM will be used to obtain cardiac output, stroke volume, and fluid responsiveness.	Device: NICOM; Use of NICOM and PLR to obtain patient fluid status

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Fluid responsiveness	If patient is fluid responsive, Stroke Volume Index (SVI) will increase by 10% or greater compared to its baseline	within 30 minutes post-anesthesia induction

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Cheetah Medical Inc.
• Investigators: Principal Investigator: Andrew Stasic, MD, Indiana University

Study record dates

Study Major Dates

• Study Start: July 17, 2016
• Primary Completion (Actual): July 21, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 27, 2016

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: cardiac monitoring, Cheetah Medical, passive leg raises
• Additional Relevant MeSH Terms: Pathologic Processes; Hypovolemia
• Other Study ID Numbers: 1508764960

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO