Uninvasive Cardiac Output Monitoring (USCOM) in Critically Ill Children: Validation and Prediction of Hemodynamic Instability

March 14, 2021 updated by: Rabin Medical Center

Hemodynamically unstable ventilated PICU & PCICU patients, which a decision for commencement in inotropic therapy or fluid bolus has been made, will be recruited. Hemodynamic measurements will be carried out before and after therapy have been made, including customary hemodynamic parameters, echocardiography and USCOM studies.

All parameters will be analyzed for fluid responsiveness or inotropic therapy prediction. Trend in USCOM parameters will be compared to echocardiography CO parameters.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Petach tikva, Israel
        • Schneider's children medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 days to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric critically ill ventilated patients addmited to PICU & PCICU

Description

Inclusion Criteria:

  • Pediatric critically ill ventilated patients admitted to PICU & PCICU
  • Hemodynamically unstable which a decision for commencement in inotropic therapy or fluid bolus has been made
  • parental concent

Exclusion Criteria:

  • Cardiac shunt
  • Aortal anomaly \ Repair
  • Tracheostomy
  • Parental refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Raise>10% in cardiac index following therapy
Time Frame: 20 minutes
20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rabin Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

August 1, 2020

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

October 25, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 14, 2021

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0693-14-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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