Non-invasive Cardiac Output Monitor in Young Adults

NCT ID: NCT02813915

Last Updated: 2018-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-17

Study Completion Date

2018-03-01

Brief Summary

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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

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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.

Conditions

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Fluid Overload Hypovolemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

NICOM

Intervention Type DEVICE

Use of NICOM and PLR to obtain patient fluid status

Interventions

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NICOM

Use of NICOM and PLR to obtain patient fluid status

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cheetah Medical Inc.

INDUSTRY

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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Andrew Stasic

Associate Professor of Clinical Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Stasic, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Other Identifiers

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1508764960

Identifier Type: -

Identifier Source: org_study_id

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