Non-invasive Cardiac Output Monitor in Young Adults

Completed

• Conditions: Fluid Overload; Hypovolemia

• Registration Number: NCT02813915
• Lead Sponsor: Indiana University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-27
• Study Start: 2016-07-17
• Primary Completion: 2017-07-21
• Study Completion: 2018-03-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-02
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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