Atrial Fibrillation Fluttering
Conditions
Keywords
ankle - brachial index
Brief summary
Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical cardioversion. Ankle brachial index will be measured three times with oscillometric method and three times with doppler method. Two study sessions will be performed: the first before and the second after electrical cardioversion. The first session will be ended before anesthesia. The second session will be started before a conscious patient will be transported from intensive care unit to general ward. All the measurements will be taken in the intensive care unit at an ambient temperature of 21° C, after patients will give their written informed consent to participate in the study. All patients will be awake, fasting and in the supine position. ABI will be measured according to the guidelines issued by AHA. Systolic blood pressure will be measured using a Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric method will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau, Switzerland). The appropriate cuff size will be used with the width of the cuff being at least 40% of the limb circumference. The arm with higher systolic blood pressure will be used to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial or dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI measurements will be repeated 3 times with each method in the reverse order of the preceding measurement e.g., in the case of the initial counterclockwise sequence: right arm, right popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm, the clockwise sequence will be used, starting and ending with the left arm. The same sequence of limb pressure measurements will be used used during the study. A sample size calculation was based on the preliminary observations made by the study team. It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size of 115 patients incorporated an assumption of dropout due to non-effective electrical cardioversion, patient decision to quit study or failure to obtain adequate ABI. The measurements will be repeated three times with each method and for the each method the mean will be used for the calculations. Investigator - study nurse, trained at the vascular department, will perform all ABI measurements.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
* Patients undergoing electrical cardioversion due to atrial fibrillation
Exclusion criteria
* Circulatory instability * Use of vasoconstrictive agents * Limb trauma * Upper limb artery stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). | Through the study | 3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method. | Through the study period | 3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants |
Participant flow
Recruitment details
One hundred and fifteen consecutive patients with atrial fibrillation admitted to Department of Internal Medicine, Hypertension and Vascular Diseases, Medical University of Warsaw for electrical cardioversion were screened. Participants were recruited to the study from October 2012 up to December 2015.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Interventions - repeated ankle - brachial index measurement before and after electrical cardioversion in patients with atrial fibrillation
ABI measurement using both doppler and oscillometric method. | 99 |
| Total | 99 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 61 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 66.5 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 99 Participants |
| Region of Enrollment Poland | 99 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric).
3 ABI measurements using both methods (doppler and oscillometric) were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants.
Time frame: Through the study
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Single Arm | Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). | ABI oscillometric before | 1.21 ratio |
| Single Arm | Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). | ABI oscillometric after | 1.215 ratio |
| Single Arm | Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). | ABI doppler before | 1.14 ratio |
| Single Arm | Difference Between ABI (Ankle - Brachial Index) Before Electrical Cardioversion Using Two Methods (Doppler and Oscillometric). | ABI doppler after | 1.18 ratio |
Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method.
3 ABI measurements using doppler method were performed per participant and the Mean value was considered for each participant, and then a Median value was calculated across participants
Time frame: Through the study period
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Single Arm | Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method. | ABI doppler before | 1.14 ratio |
| Single Arm | Difference Between ABI Measured Before and After Electrical Cardioversion Using Doppler Method. | ABI doppler after | 1.18 ratio |