PURPOSE: To assess optimal bed-rest duration after vascular intervention by way of the common femoral artery using 3F introducer sheaths. MATERIALS AND METHODS: Eligibility criteria for this single-center, prospective study included clinically necessary angiography, no coagulopathy or anticoagulant therapy, no hypersensitivity to contrast medium, age >20 years, and written, informed consent. Enrolled patients were assigned to one of three groups (105/group) with the duration of bed rest deceased sequentially. A sheath was inserted by way of the common femoral artery using the Seldinger technique. The first group (level 1) received 3 h of bed rest after the vascular intervention. If no bleeding or hematomas developed, the next group (level 2) received 2.5 h of bed rest. If still no bleeding or hematomas developed, the final group (level 3) received 2 h of bed rest. If any patient had bleeding or hematomas after bed rest, the study was terminated, and the bed rest of the preceding level was considered the optimal duration. RESULTS: A total of 105 patients were enrolled at level 1 between November 2010 and September 2011. Eight patients were excluded from analysis because cessation of bed rest was delayed. None of the remaining subjects experienced postoperative bleeding; therefore, patient enrollment at level 2 began in September 2011. However, puncture site bleeding occurred in the 52nd patient immediately after cessation of bed rest, necessitating study termination. CONCLUSION: To prevent bleeding, at least 3 h of postoperative bed rest is recommended for patients undergoing angiography using 3F sheaths.
RCT Entities:
PURPOSE: To assess optimal bed-rest duration after vascular intervention by way of the common femoral artery using 3F introducer sheaths. MATERIALS AND METHODS: Eligibility criteria for this single-center, prospective study included clinically necessary angiography, no coagulopathy or anticoagulant therapy, no hypersensitivity to contrast medium, age >20 years, and written, informed consent. Enrolled patients were assigned to one of three groups (105/group) with the duration of bed rest deceased sequentially. A sheath was inserted by way of the common femoral artery using the Seldinger technique. The first group (level 1) received 3 h of bed rest after the vascular intervention. If no bleeding or hematomas developed, the next group (level 2) received 2.5 h of bed rest. If still no bleeding or hematomas developed, the final group (level 3) received 2 h of bed rest. If any patient had bleeding or hematomas after bed rest, the study was terminated, and the bed rest of the preceding level was considered the optimal duration. RESULTS: A total of 105 patients were enrolled at level 1 between November 2010 and September 2011. Eight patients were excluded from analysis because cessation of bed rest was delayed. None of the remaining subjects experienced postoperative bleeding; therefore, patient enrollment at level 2 began in September 2011. However, puncture site bleeding occurred in the 52nd patient immediately after cessation of bed rest, necessitating study termination. CONCLUSION: To prevent bleeding, at least 3 h of postoperative bed rest is recommended for patients undergoing angiography using 3F sheaths.