4104 A Study to Assess Retention Cuff Pressure Measurements of Three Stool Management Systems

Laurence R. Sands, MD , Miller School of Medicine, University of Miami, Chief, Division of Colon and Rectal Surgery, Miami, FL
Joseph P. Corallo, MD , Miller School of Medicine, University of Miami, Fellow, Colon and Rectal Surgery, Miami, FL
Floriano Marchetti, MD , Miller School of Medicine, University of Miami, Assistant Professor of Surgery, Miami, FL
Jaime Ritter, MPH, CIC , C. R. Bard, Inc., Clinical Manager, Covington, GA
Background: Fecal incontinence and diarrhea are common in critically ill patients and, if unmanaged, may lead to incontinence-associated dermatitis.  Management of these patients can be labor intensive and complex.  Several stool management systems (SMS) designed to divert and contain semi-liquid/liquid feces are now available and their clinical use is increasing.   SMS utilize a retention cuff designed to maintain placement in the rectal vault; however, tissue damage has been reported.
Methods:  This study was designed to measure retention cuff pressure of three commercially available SMS.  Ten healthy subjects were enrolled; all subjects received Device A and were randomized to receive either Device B or Device C.  Pressure measurements were taken with the subject in various positions (e.g., side, supine, elevated head-of-bed).  Endoscopic examination was also performed before, during, and after SMS placement to assess rectal vault tissue and cuff seating.
Results:  Overall, mean cuff pressure for Device A was 31 mm/Hg (16-48 mm/Hg), for Device B was 81 mm/Hg (60-106 mm/Hg), and for Device C was 73 mm/Hg (58-88 mm/Hg).  These differences were statistically significant (p<0.05).  Cuff pressures were lowest when the subjects were on their side; pressure increased when the subjects were in a supine position and when the head-of-bed was elevated.  There were no endoscopically detectable differences in cuff seating between the three SMS; however, function was not assessed in this study.
Conclusions:  SMS examined in our study utilize different retention cuff designs.  While all appear to seat well within the rectal vault, there were significant differences in pressure measurements.  Low cuff pressure devices may transmit less pressure to the rectal mucosa; however, the clinical relevance of these cuff pressure differences is not yet known.
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