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The purpose of this study is to investigate the intra-abdominal pressure utilizing the Accuryn monitoring system during pulsed field ablation procedures in the electrophysiology lab compared to the type of anesthetic utilized.
Intra-abdominal pressure (IAP) may play a role in patient outcomes during ablation procedures, as increased IAP could indicate potential adverse events. Such adverse events include aspiration of stomach contents, which can lead to respiratory issues post procedure and unplanned admission to the hospital post procedure. Potrero Medical has manufactured a foley based monitoring system that has been FDA cleared for the indication of measuring intra-abdominal pressure. The Accuryn monitor allows for continuous, real-time measurement of IAP and urine output, providing data that may enhance procedural safety and provide insights into any physiological responses unique to Pulsed Field Ablation (PFA). This study aims to compare PFA in terms of safety, efficacy, and IAP changes based on type of anesthesia received.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Accuryn Foley catheter placement | Experimental | foley catheter is made to measure intra-abdominal pressure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accuryn Foley catheter device | Device | Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia | intra-abdominal pressure during PFA when general anesthetic is utilized | hour 2 |
| Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation | intra-abdominal pressure during PFA when anesthesia is sedation | hour 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hiccups | incidence of hiccups occurring during the planned procedure | hour 2 |
| Amount oral secretions | Amount of oral secretions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karuna Rajkumar, MD | Contact | 832-707-0858 | kputturr@wakehealth.edu |
| Name | Affiliation | Role |
|---|---|---|
| Karuna Rajkumar, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Health Sciences | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Term |
|---|---|
| D059325 | Intra-Abdominal Hypertension |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| ID | Term |
|---|---|
| D003161 | Compartment Syndromes |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
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| hour 2 |
| Number of post-operative intubations | Number of incidences requiring postoperative intubation after procedure | hour 2 |
| Total urine output | Total urine output | hour 2 |
| Number of urinary tract infections | Number of urinary tract infections in the week postoperatively | day 7 |
| Number of unplanned admissions to the hospital | Number of unplanned admissions to the hospital | hour 2 |
| D002318 |
| Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |