Trials / Completed
CompletedNCT02378155
Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Hasselt University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SenSmart Model X-100, Nonin Medical | Device to measure cerebral tissue oxygen saturation |
Timeline
- Start date
- 2015-02-01
- Primary completion
- 2015-06-01
- First posted
- 2015-03-04
- Last updated
- 2015-08-19
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT02378155. Inclusion in this directory is not an endorsement.