Non-invasive Cardiac Output Monitor 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.

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Key information

Conditions

Fluid Overload Edema Hypovolemia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NICOM

Device

Use of NICOM and PLR to obtain patient fluid status

Primary outcomes

Patient Fluid responsiveness

Time frame: 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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

Cheetah Medical Inc.

Registry information

Official study title

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

Acronym: NICOM

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2018
First posted: Jun 27, 2016
Registry last updated: Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed