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Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

Primary Purpose

Electrical Cardioversion of Atrial Fibrillation, Pharmacological Cardioversion of Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

SenSmart Model X-100, Nonin Medical

About this trial

This is an interventional supportive care trial for Electrical Cardioversion of Atrial Fibrillation focused on measuring cardioversion, atrial fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ziekenhuis Oost-Limburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

electrical cardioversion

pharmacological cardioversion

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion

Secondary Outcome Measures

Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation

Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other

Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction

Perform neuropsychological tests before and after electrical/pharmacological cardioversion

Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status

Compare the response of the pulse oximetry with the effects on the neurocognitive status

Compare the response of the blood pressure with the effects on the neurocognitive status

Full Information

NCT ID

NCT02378155

First Posted

December 17, 2014

Last Updated

August 18, 2015

Sponsor

Hasselt University

1. Study Identification

Unique Protocol Identification Number

NCT02378155

Brief Title

Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hasselt University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Electrical Cardioversion of Atrial Fibrillation, Pharmacological Cardioversion of Atrial Fibrillation

Keywords

cardioversion, atrial fibrillation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

electrical cardioversion

Arm Type

Other

Arm Description

Arm Title

pharmacological cardioversion

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

SenSmart Model X-100, Nonin Medical

Intervention Description

Device to measure cerebral tissue oxygen saturation

Primary Outcome Measure Information:

Title

Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation

Time Frame

6 months

Title

Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other

Time Frame

6 months

Title

Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction

Time Frame

6 months

Title

Perform neuropsychological tests before and after electrical/pharmacological cardioversion

Time Frame

6 months

Title

Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status

Time Frame

6 months

Title

Compare the response of the pulse oximetry with the effects on the neurocognitive status

Time Frame

6 months

Title

Compare the response of the blood pressure with the effects on the neurocognitive status

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cornelia Genbrugge, MD

Organizational Affiliation

Hasselt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ziekenhuis Oost-Limburg

City

Genk

State/Province

Limburg

ZIP/Postal Code

3600

Country

Belgium

12. IPD Sharing Statement

Citations:

PubMed Identifier

20580625

Citation

Pellicer A, Bravo Mdel C. Near-infrared spectroscopy: a methodology-focused review. Semin Fetal Neonatal Med. 2011 Feb;16(1):42-9. doi: 10.1016/j.siny.2010.05.003. Epub 2010 Jun 26.

Results Reference

background

PubMed Identifier

23902651

Citation

Wutzler A, Nee J, Boldt LH, Kuhnle Y, Graser S, Schroder T, Haverkamp W, Storm C. Improvement of cerebral oxygen saturation after successful electrical cardioversion of atrial fibrillation. Europace. 2014 Feb;16(2):189-94. doi: 10.1093/europace/eut246. Epub 2013 Jul 31.

Results Reference

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Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

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