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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electrical cardioversion | Other | 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. |
|
| pharmacological cardioversion | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenSmart Model X-100, Nonin Medical | Device | Device to measure cerebral tissue oxygen saturation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion | 6 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cornelia Genbrugge, MD | Hasselt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuis Oost-Limburg | Genk | Limburg | 3600 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20580625 | Background | 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. | |
| 23902651 | Background | 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. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |