Heart Rate Variability in Extracorporeal Membrane Oxygenation (ECMO) Patients

April 21, 2011 updated by: National Taiwan University Hospital

Clinical Application of Multimodal Physiological Signal Analysis in Critical Ill Patients Depending on Extracorporeal Membrane Oxygenation

National Taiwan University Hospital is the leading center for care of patients with extracorporeal membrane oxygenation (ECMO). The predictable factors associated with outcomes are still lacking in patients with the ECMO support. The aim of this study is to collect the electrical signals stored in the monitor of intensive care units (ICUs), which are analyzed by the bio-informatics software. The pre-, peri-, and post-ECMO heart rate variability, including linear and non-linear analysis is calculated to address the association with outcomes of patients with ECMO. In addition, we collected the demographics, body temperature, respiratory rate, and blood pressure to investigate the causes of heart rate variability.

Study Overview

Status

Unknown

Conditions

Detailed Description

Inclusion criteria:Adults patients (aged older than 18 years; less than 90 years old) used ECMO for cardiopulmonary support

Exclusion criteria:

  1. Patients used illicit drugs
  2. Patients received heart transplantation
  3. Patients have the history of arrhythmia

Study Type

Observational

Enrollment (Anticipated)

40

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

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

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

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with the support of extracorporeal membrane oxygenation

Description

Inclusion Criteria:

  • Adults patients (aged > 18 years; less than 90 years old) used ECMO for cardiopulmonary support

Exclusion Criteria:

  • Patients used illicit drugs
  • Patients received heart transplantation
  • Patients have the history of arrhythmia

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-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

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

Sponsor

National Taiwan University Hospital

Investigators

  • Study Chair: Wen-Je Ko, M.D., Ph.D., National Taiwan University Hospital

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, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

April 22, 2011

Last Update Submitted That Met QC Criteria

April 21, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201010075R

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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