Clinical trial NCT02378155: Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electrical Cardioversion of Atrial Fibrillation
Pharmacological Cardioversion of Atrial Fibrillation
Keywords: cardioversion
atrial fibrillation
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion
timeFrame: 6 months
Secondary outcomes:
measure: Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation
timeFrame: 6 months
measure: Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other
timeFrame: 6 months
measure: Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction
timeFrame: 6 months
measure: Perform neuropsychological tests before and after electrical/pharmacological cardioversion
timeFrame: 6 months
measure: Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status
timeFrame: 6 months
measure: Compare the response of the pulse oximetry with the effects on the neurocognitive status
timeFrame: 6 months
measure: Compare the response of the blood pressure with the effects on the neurocognitive status
timeFrame: 6 months
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Hasselt University
name: Cornelia Genbrugge, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.