title: Retention cuff pressure study of 3 indwelling stool management systems: randomized study of 10 healthy subjects.
abstract: OBJECTIVE
  The purpose of this study was to compare retention cuff pressures of 3 indwelling stool management systems while subjects assumed different body positions and while cuffs were inflated to different volumes.
  
  
  METHODS
  Retention cuff pressure study of 3 indwelling stool management systems was a randomized, crossover, open-label pilot study of 10 healthy adult volunteers in 3 body positions (supine, right side, and left side), 3 head-of-bed elevations (20°, 30°, and 40°), and 3 cuff overfill volumes (5, 10, and 15 mL). The devices were DigniCare Stool Management System (device A; Bard Medical Division, C. R. Bard, Inc, Covington, Georgia), Flexi-Seal Fecal Management System (device B; ConvaTec, a division of E. R. Squibb & Sons, LLC, Princeton, New Jersey), and ActiFlo Indwelling Bowel Catheter System (device C; Hollister, Inc, Libertyville, Illinois). We assessed cuff pressure by manometry and rectal mucosa by digital examination and small-diameter, flexible endoscopy.
  
  
  RESULTS
  Cuffs were appropriately seated in the rectal vault for all 3 devices in all body positions and overfill volumes. Rectal mucosal abnormalities were observed in 4 of 10 subjects (40%) after removal of device A, 1 of 5 (20%) after removal of device B, and 3 of 5 (60%) after removal of device C. Retention cuff pressure was at least 2-fold lower for device A than for device B or C in all body positions, head-of-bed elevations, and device overfill volumes. For example, mean pressure while subjects were on their left sides was 25.0 mm Hg for device A, 79.2 mm Hg for device B, and 67.2 mm Hg for device C. Corresponding pressures at 15 mL of overfill were 52.5, 102.0, and 94.0 mm Hg. Subject comfort scores were comparable for all 3 devices.
  
  
  CONCLUSIONS
  All devices appeared to seat well within the rectal vault, but device A was associated with cuff pressure measurements that were consistently lower than those of devices B and C. More studies are needed to elucidate the clinical relevance of these findings and whether they translate to differences in patient safety or comfort.
authors.affiliation: University of Miami Miller School of Medicine, University of Miami Hospital, Miami, Florida, USA.
authors.forename: Floriano
authors.initials: F
authors.lastname: Marchetti
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Corallo
authors.forename: Jaime
authors.initials: J
authors.lastname: Ritter
authors.forename: Laurence R
authors.initials: LR
authors.lastname: Sands
mesh_terms: D000328:Adult; D018592:Cross-Over Studies; D004867:Equipment Design; D004869:Equipment Safety; D005242:Fecal Incontinence / Q000517:prevention & control; D005260:Female; D006801:Humans; D008297:Male; D008365:Manometry / Q000295:instrumentation* / Q000379:methods; D008875:Middle Aged; D010865:Pilot Projects; D011312:Pressure; D011351:Proctoscopy / Q000379:methods; D012007:Rectum / Q000502:physiology*; D012016:Reference Values; D012680:Sensitivity and Specificity; D016037:Single-Blind Method; D055815:Young Adult