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Non-invasive Cardiac Output Monitor in Young Adults (NICOM)

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ClinicalTrials.gov Identifier: NCT02813915
Recruitment Status : Completed
First Posted : June 27, 2016
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
Cheetah Medical Inc.
Information provided by (Responsible Party):
Andrew Stasic, Indiana University

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.

Condition or disease Intervention/treatment
Fluid Overload Hypovolemia Device: NICOM

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Trial of a Non-Invasive Cardiac Output in Young Adults
Study Start Date : July 17, 2016
Actual Primary Completion Date : July 21, 2017
Actual Study Completion Date : March 1, 2018

Group/Cohort Intervention/treatment
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
Use of NICOM and PLR to obtain patient fluid status




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18-30 years of age having surgery at Riley or University Hospital
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02813915


Sponsors and Collaborators
Indiana University
Cheetah Medical Inc.
Investigators
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Principal Investigator: Andrew Stasic, MD Indiana University
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Responsible Party: Andrew Stasic, Associate Professor of Clinical Anesthesia, Indiana University
ClinicalTrials.gov Identifier: NCT02813915    
Other Study ID Numbers: 1508764960
First Posted: June 27, 2016    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Andrew Stasic, Indiana University:
cardiac monitoring, Cheetah Medical, passive leg raises
Additional relevant MeSH terms:
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Hypovolemia
Pathologic Processes