NCT02813915

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
20 days until next milestone

Study Start

First participant enrolled

July 17, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

June 22, 2016

Last Update Submit

October 2, 2018

Conditions

Fluid OverloadHypovolemia

Keywords

cardiac monitoring, Cheetah Medical, passive leg raises

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Device: NICOM

Interventions

NICOMDEVICE

Use of NICOM and PLR to obtain patient fluid status

Use of Cheetah medical NICOM

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients 18-30 years of age having surgery at Riley or University Hospital

You may qualify if:

  • years of age
  • presenting for surgery at Riley or University Hospital

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EdemaHypovolemia

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Andrew Stasic, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical Anesthesia

Study Record Dates

First Submitted

June 22, 2016

First Posted

June 27, 2016

Study Start

July 17, 2016

Primary Completion

July 21, 2017

Study Completion

March 1, 2018

Last Updated

October 3, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share