Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

August 18, 2015 updated by: Cornelia Genbrugge, Hasselt University

Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a numeric result can be calculated.

Since atrial fibrillation (AF) has been linked with an increased risk for the development of neurocognitive deficits, a longer period of AF might be associated with a higher risk for neurocognitive deficits.

It is hypothesized that there is an increase in the regional cerebral oxygen saturation (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Written informed consent by the patient is asked before cardioversion and participation in the study. Patient anamnesis is assessed by standardized questionnaire.

Patients perform several standardised neurocognitive tests to obtain a general view on the neurocognitive status (auditory verbal learning test, mini-mental state examination, trail making A and B, digit-symbol coding and RAND 36 Health Survey).

Cerebral oxygenation is observed during cardioversion by means of the SenSmart Model X-100 (Nonin). Additional parameters (pulse oximetry, cardiac output, arterial blood pressure, 6-lead electrocardiography (ECG), left ventricular ejection fraction) are recorded. All measurements are performed non-invasively. Patients receive standard treatment following the clinical guidelines.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

  • Belgium
    • Limburg
      • Genk, Limburg, Belgium, 3600
        • Ziekenhuis Oost-Limburg

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • older than 18 years and able to give informed consent
  • diagnosis of paroxysmal or persistent atrial fibrillation
  • scheduled for electrical cardioversion or atrial fibrillation development in the first days after cardiac surgery followed by pharmacological treatment with amiodarone
  • Dutch speaking

Exclusion Criteria:

  • younger than 18 years or not able to give informed consent
  • diagnosis of permanent atrial fibrillation
  • atrial fibrillation with thrombus in left atrial appendage
  • chronic obstructive pulmonary disease GOLD class 3 or 4
  • airway manipulation during cardioversion
  • pregnant women
  • medical history of cerebrovascular accident or brain injury
  • medical history of cardiopulmonary resuscitation

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

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: electrical cardioversion
Hemodynamic unstable patients with atrial fibrillation who are scheduled to undergo electrical reconversion to convert their irregular heart rhythm into a normal sinus rhythm. Cerebral tissue oxygen saturation is measured by means of SenSmart Model X-100, Nonin Medical.
Device: SenSmart Model X-100, Nonin Medical
Device to measure cerebral tissue oxygen saturation
Other: pharmacological cardioversion
Patients who develop atrial fibrillation after cardiac surgery. Pharmacological treatment with amiodarone is started in order to convert their irregular heart rhythm into a normal sinus rhythm. Cerebral tissue oxygen saturation is measured by means of SenSmart Model X-100, Nonin Medical.
Device: SenSmart Model X-100, Nonin Medical
Device to measure cerebral tissue oxygen saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation
Time Frame: 6 months
6 months
Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other
Time Frame: 6 months
6 months
Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction
Time Frame: 6 months
6 months
Perform neuropsychological tests before and after electrical/pharmacological cardioversion
Time Frame: 6 months
6 months
Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status
Time Frame: 6 months
6 months
Compare the response of the pulse oximetry with the effects on the neurocognitive status
Time Frame: 6 months
6 months
Compare the response of the blood pressure with the effects on the neurocognitive status
Time Frame: 6 months
6 months

Collaborators and Investigators

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

Sponsor

Hasselt University

Investigators

  • Principal Investigator: Cornelia Genbrugge, MD, Hasselt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

February 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

December 17, 2014

First Submitted That Met QC Criteria

February 26, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AF I

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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