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NCT02813915 Clinical Trial

Non-invasive Cardiac Output Monitor in Young Adults

Fluid Overload Clinical Trial

— NICOM  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02813915
Other study ID # 1508764960
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 17, 2016
Est. completion date March 1, 2018

Study information
Verified date October 2018
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 1, 2018
Est. primary completion date July 21, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• NICOM
Use of NICOM and PLR to obtain patient fluid status

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Indiana University Cheetah Medical Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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