Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

Hasselt University

Status: Completed

Conditions: Electrical Cardioversion of Atrial Fibrillation; Pharmacological Cardioversion of Atrial Fibrillation

Treatments: Device: SenSmart Model X-100, Nonin Medical

Study type: Interventional

Funder types: Other

Identifiers

NCT02378155

AF I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

electrical cardioversion

Other group

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.

Treatment:

Device: SenSmart Model X-100, Nonin Medical

pharmacological cardioversion

Other group

Description:

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.

Treatment:

Device: SenSmart Model X-100, Nonin Medical