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Non-invasive Cardiac Output Monitor in Young Adults

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02813915
Acronym
NICOM
Enrollment
50
Registered
2016-06-27
Start date
2016-07-17
Completion date
2018-03-01
Last updated
2018-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Overload, Hypovolemia

Keywords

cardiac monitoring, Cheetah Medical, passive leg raises

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.

Interventions

DEVICENICOM

Use of NICOM and PLR to obtain patient fluid status

Sponsors

Cheetah Medical Inc.
CollaboratorINDUSTRY
Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Fluid responsivenesswithin 30 minutes post-anesthesia inductionIf patient is fluid responsive, Stroke Volume Index (SVI) will increase by 10% or greater compared to its baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026