Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

Study Overview
=================
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.

Conditions
-----------------
Electrical Cardioversion of Atrial Fibrillation, Pharmacological Cardioversion of Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: SenSmart Model X-100, Nonin Medical


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: electrical cardioversion<br>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<br>* Device to measure cerebral tissue oxygen saturation<br>|
| Other: pharmacological cardioversion<br>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<br>* Device to measure cerebral tissue oxygen saturation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardioversion, atrial fibrillation