Non-invasive Cardiac Output Monitor in Young Adults | NCT02813915

Studies
Non-invasive Cardiac Output Monitor in Young Adults

NCT02813915

Sponsor

Indiana University

Status

Completed

Last Update Posted

Oct 3, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Fluid Overload
Hypovolemia

Interventions

NICOM

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 17, 2016

Primary Completion Date

Jul 21, 2017Actual

Completion Date

Mar 1, 2018Actual

First Submitted Date

Jun 22, 2016

First Submission Date that Met QC Criteria

Jun 22, 2016

First Posted Date

Jun 27, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2018

Last Update Posted Date

Oct 3, 2018Actual

Name	Class
Cheetah Medical Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NICOM	Device	Use of NICOM and PLR to obtain patient fluid status	Use of Cheetah medical NICOM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Andrew Stasic, MD	Indiana University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D004487	Edema
D020896	Hypovolemia

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided