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Completed

NCT Number: NCT02378155

Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation

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.

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Key information

Conditions

Electrical Cardioversion of Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharmacological Cardioversion of Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SenSmart Model X-100, Nonin Medical

Device

Device to measure cerebral tissue oxygen saturation

Primary outcomes

  1. Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion

    Time frame: 6 months

Secondary outcomes

  1. Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation

    Time frame: 6 months

  2. Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other

    Time frame: 6 months

  3. Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction

    Time frame: 6 months

  4. Perform neuropsychological tests before and after electrical/pharmacological cardioversion

    Time frame: 6 months

  5. Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status

    Time frame: 6 months

  6. Compare the response of the pulse oximetry with the effects on the neurocognitive status

    Time frame: 6 months

  7. Compare the response of the blood pressure with the effects on the neurocognitive status

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
First posted
Mar 4, 2015
Registry last updated
Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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