Barnes-Jewish Hospital’s Experience with a New Femoral Hemostasis Device

The authors share the results of a study done at their facility comparing the AVD ComfortPress device with manual compression in patients receiving a 4 Fr arterial sheath. _________________________ In the interest of quality improvement and safety, new technology, techniques and equipment are often examined and evaluated by nursing staff at Barnes-Jewish Hospital at Washington University Medical Center (a Magnet hospital). In 2007, such an opportunity arose when a new product, the ComfortPress™ Manual Compression Assist Device [Advanced Vascular Dynamics (AVD), Portland, OR] was introduced to Barnes-Jewish Hospital’s Cardiovascular Procedure Center (CPC) for trial. This novel, FDA-cleared device is marketed as a tool clinicians can use to safely apply external compression to an arterial puncture site, while potentially providing relief for joint and muscle exertion of the clinician removing the sheath. It is available in a small grip and a large grip size to accommodate different hand sizes. The ergonomic design enhances comfort for the clinician as well as the patient. OSHA (the U.S. Dept. of Labor’s Occupational Safety and Health Administration) reports that there is a risk of disability when certain tasks or procedures are repeatedly performed by the same clinician or worker. The manual removal of an arterial sheath is one such example. Common sites for clinician discomfort and strain while performing this task include the fingertips, metacarpophalangeal joints in the hand, as well as the wrist joint. Ergonomics and Hemostasis in the PRA Following most procedures at the CPC, patients are transported to a 20-bed prep and recovery area (PRA) for recovery and sheath removal. Sheath size depends on the type of procedure and varies from 6 French (Fr) to 8 Fr. During a left heart catheterization (LHC), arterial access is obtained using a 4 Fr sheath, while a larger sheath is used to perform a percutaneous coronary intervention (PCI). The PRA is staffed daily with a triage nurse, five to six staff nurses, and one to two patient care technicians. Each nurse may be required to manually remove, on average, three sheaths per day. The primary role of the patient care technician is sheath removal; therefore, they remove the majority of the sheaths. In a typical day, 25 sheaths may be manually removed by the nursing and technician staff. Discomfort and fatigue of the hand and fingers is often reported by staff members during and after sheath removal. “I can hardly close my hand to grip a pen after pulling an 8 Fr sheath,” reports Ann Hinrichs, RN, staff nurse in the PRA. Hemostasis techniques used for LHC and PCI include manual compression, mechanical compression and invasive closure devices. Patients undergoing a LHC who do not require a PCI have their sheath removed in the recovery area immediately following the procedure. Manual compression to achieve hemostasis has been the preferred method of sheath removal for these patients during the past several years. In patients requiring a PCI, mechanical closure devices such as Angio-Seal (St. Jude Medical, Minnetonka, MN) and the Perclose Proglide (Abbott Vascular, Redwood City, CA) are the preferred method of removal for 6 Fr or larger sheaths. However, if the arterial stick is not in the ideal location (below the bifurcation of the profunda and superficial femoral artery), manual compression is required. Length of manual compression time on the arterial access site generally depends on the size of the sheath. Larger sheaths will require longer hold time. In the CPC, the average compression time for a 4 Fr sheath is 10-12 minutes. An 8 Fr sheath requires 20-25 minutes for hemostasis. Anticoagulation and antiplatelet medications used during PCIs will also influence compression times and hemostasis. An activated clotting time (ACT) of less than 180 seconds is the standard in the CPC for sheath removal. A core group of nurses who primarily work in the cardiac catheterization division of the CPC joined together to form a research group to evaluate a new device to assist with hemostasis of arterial access, the ComfortPress. A review of the literature revealed data on patient complications post-sheath removal; however, little evidence was found on hand fatigue and nurse confidence/satisfaction. Principal investigator Beverly Dressel, RN, along with Anne Digue, RN, and Rhonda Pugh, RN, developed a post test only study comparing the ComfortPress with the PRA’s current practice of using the fingers for manual compression during removal of 4 Fr arterial sheaths. Methods Standardized protocols were outlined for both manual compression and ComfortPress-assisted compression. Placement of compression and compression times were the same for both techniques. A post-test survey was created, consisting of an eight-item Likert scale measuring hand fatigue, confidence in adequate hemostasis and satisfaction of the clinician removing the sheath. A power analysis indicated a minimum sample of 70 sheath removals were required to prove statistical significance. IRB approval was obtained before the study commenced. Patients were randomly placed in one of two groups based on the day of the week. The two compression techniques were alternated every other day. Five staff members from the PRA were recruited to participate in this randomized study. All were trained and proctored on usage of the device by AVD. Complications during sheath removal were recorded as part of the data collection. A total of 89 sheath removals were completed for the study and used in the data analysis. Independent sample t-tests were used to determine outcome differences between manual compression and the ComfortPress Manual Compression Assist Device. Results There was no statistically significant difference in hand fatigue or confidence/satisfaction of the clinician removing the sheaths. Since only 4 Fr sheaths were included in the study, it is assumed the relatively short compression times required for this size sheath may account for this result. However, a statistically significant difference in hematoma formation was discovered. The ComfortPress group was shown to have less hematoma formation [mean (M) = 1.88, standard deviation (SD) = 0.31] than the manual compression group [M = 2.00, SD = 0.00; t-test(89) = 2.55, p-value = 0.00. Note: The SPSS statistical package only reports to three units after the decimal point]. One hematoma was reported in the ComfortPress group, while four hematomas were reported in the manual compression group. Study Limitations Limitations identified for this study include a small sample size and using only 4 Fr arterial sheath removals, which have shorter compression times. Discussion The ComfortPress device may afford more stable compression since there is less opportunity for fingertip motion while holding pressure over the arterial puncture site. Since this study was performed, the Cardiovascular Procedure Center at Barnes-Jewish Hospital has adopted the ComfortPress as a safe alternative to manual compression for sheath removal. A Phase II study is currently under IRB review and will evaluate the use of the ComfortPress Manual Compression Assist Device on patients requiring larger sheath sizes (up to 8 Fr), and on patients receiving anticoagulation and antiplatelet therapy. Since larger sheath sizes and anticoagulation/antiplatelet therapy require longer compression times, it is possible that more pronounced clinician hand fatigue may be observed. Acknowledgements. The authors wish to thank Margaret Ulione, PhD, RN, and Jennifer Sledge, MSW, both from the Barnes Jewish Hospital Center for Research, Carla Ashmead, RN, BSN, MBA, Clinical Nurse Manager of the CPC, and Catherine Powers RN, MSN, ACNS-BC, Clinical Nurse Specialist, Heart Services, as well as Matt Semler and Troy Hunting from Advanced Vascular Dynamics for their continued support and guidance with this research project. The authors can be contacted via Beverly Dressel at bjd3823@bjc.org

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