Intra-Abdominal Hypertension
Conditions
Keywords
Atrial Fibrillation, Atrial Flutter, Pulsed Field Ablation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAccuryn Foley catheter device
Accuryn foley catheter placed on all subjects after consent who are having treatment for atrial flutter or atrial fibrillation
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients receiving pulse field ablation procedures for standard of care treatment of atrial fibrillation and/or atrial flutter. * Eligible for Foley catheter placement with no contraindications to Intra-abdominal pressure (IAP) monitoring.
Exclusion criteria
* Patients under the age of 18 will be excluded. * History of intra-abdominal surgery within the past 6 months. * Known contraindications to bladder catheterization or catheter ablation; history of prostate issues / Benign prostatic hyperplasia (BPH) or frequent urinary tract infections * Pregnant or breastfeeding individuals * History of chronic obstructive pulmonary disease (COPD) with home oxygen use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-abdominal pressure under Pulsed Field Ablation (PFA) under general anesthesia | hour 2 | intra-abdominal pressure during PFA when general anesthetic is utilized |
| Intra-abdominal pressure under Pulsed Field Ablation (PFA) under sedation | hour 2 | intra-abdominal pressure during PFA when anesthesia is sedation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hiccups | hour 2 | incidence of hiccups occurring during the planned procedure |
| Amount oral secretions | hour 2 | Amount of oral secretions |
| Number of post-operative intubations | hour 2 | Number of incidences requiring postoperative intubation after procedure |
| Total urine output | hour 2 | Total urine output |
| Number of urinary tract infections | day 7 | Number of urinary tract infections in the week postoperatively |
| Number of unplanned admissions to the hospital | hour 2 | Number of unplanned admissions to the hospital |
Countries
United States
Contacts
CONTACTKaruna Rajkumar, MD
PRINCIPAL_INVESTIGATORKaruna Rajkumar, MD
Wake Forest University Health Sciences
Outcome results
None listed