Interventional Cardiac Catheterization Graduated Mobility
Name: Jonathan Branch
Rank: MAJ, USA.
Organization: Henry M. Jackson Foundation
Performance Site: Walter Reed Army Medical Center, Washington, DC
Year Published: 1997
Abstract Status: Initial
Note: The Original PI was Virginia Spencer, 1LT, USA.The purpose of this study is to determine if graduated mobility and standing at bedside in 4 hours compared to 8 hours of bedrest decreases pain while not increasing vascular complications in patients undergoing interventional cardiac catheterization. Hypothesis: (1) Interventional cardiac catheterization patients with progressive mobility and 4 hours bedrest will report less pain than interventional cardiac catheterization patients with standard 8 hours bedrest. (2) Interventional cardiac catheterization patients with progressive mobility and 4 hours bedrest will show no greater evidence of vascular complications such as hemorrhage, hematoma, or pseudoaneurysm than interventional cardiac catheterization patients with 8 hours bedrest.In this 2 group comparison study, a convenience sample of 270 will be randomly assigned. Both groups will have the sheath removed when the activated clotting time is 170 or below followed by application of a pressure dressing and sandbag. The control group will have the sandbag removed at 4 hours but will be maintained on bedrest for 8 hours. The experimental group will receive graduated elevation of the head of the bed, the sandbag removed at 3 hours and maintained on bedrest for 4 hours.Pain will be measured by the McGill Pain Questionnaire and a visual analogue scale. Hemorrhage will be measured by weight of 4x4 dressings, hematoma by centimeter measuring tape, and pseudoaneurysm by ultrasound.Chi-square Test with Yates Correction will be used to test for differences in complications between the control and experimental group. Repeated measures of analysis of variance will be used as well as Fisher's Exact Test with and without the adjustment of the co-variates to test for differences in pain. Differences in demographic variables between the two groups will be analyzed with a Chi-Square and independent t test for categorical and continuous variables respectively. The sample will provide a 80% power to detect a 10% or greater increase in complications.