OBJECTIVE: To test the null hypothesis that there is no significant difference between 3 methods of sheath removal: manual compression, mechanical compression with the Compressar, and mechanical compression with the Femostop. METHODS: The research design was experimental. Ninety patients were randomly assigned using a random-numbers table to undergo one of 3 methods of sheath removal. The principal investigator (L.M.B.) requested the patients' consent to undergo randomization of the sheath removal. Post procedure, each patient was told which method of sheath removal he or she would undergo based on results of the random-numbers table assignment. RESULTS: There were no significant differences between the groups with regard to age, body mass index, sheath size, heparin utilization, antiplatelet agents, or use of IIb-IIIa inhibitors. The complications between the methodologies for sheath removal were statistically significant. Patients who underwent manual sheath removal had fewer complications compared with those who underwent sheath removal using the Compressar or Femostop (chi2 P = .04). When complications were compared with the other parameters, only the presence of postprocedure heparin infusion (chi2 P = .014) and ACT values (Student t test P = .044) proved to be statistically significant. CONCLUSIONS: Based on the results of this study, staff in the study setting are currently exploring manual sheath removal as the preferred practice. Randomized controlled studies with larger sample populations at multicenter research sites are needed to ensure generalizability of results to larger populations. When using manual pressure application in conjunction with closure pad devices, hold times can be decreased, thus resulting in cost savings through decreased equipment use, earlier discharge times, and improved bed utilization.
RCT Entities:
OBJECTIVE: To test the null hypothesis that there is no significant difference between 3 methods of sheath removal: manual compression, mechanical compression with the Compressar, and mechanical compression with the Femostop. METHODS: The research design was experimental. Ninety patients were randomly assigned using a random-numbers table to undergo one of 3 methods of sheath removal. The principal investigator (L.M.B.) requested the patients' consent to undergo randomization of the sheath removal. Post procedure, each patient was told which method of sheath removal he or she would undergo based on results of the random-numbers table assignment. RESULTS: There were no significant differences between the groups with regard to age, body mass index, sheath size, heparin utilization, antiplatelet agents, or use of IIb-IIIa inhibitors. The complications between the methodologies for sheath removal were statistically significant. Patients who underwent manual sheath removal had fewer complications compared with those who underwent sheath removal using the Compressar or Femostop (chi2 P = .04). When complications were compared with the other parameters, only the presence of postprocedure heparin infusion (chi2 P = .014) and ACT values (Student t test P = .044) proved to be statistically significant. CONCLUSIONS: Based on the results of this study, staff in the study setting are currently exploring manual sheath removal as the preferred practice. Randomized controlled studies with larger sample populations at multicenter research sites are needed to ensure generalizability of results to larger populations. When using manual pressure application in conjunction with closure pad devices, hold times can be decreased, thus resulting in cost savings through decreased equipment use, earlier discharge times, and improved bed utilization.