Retention cuff pressure study of 3 indwelling stool management systems: Randomized study of 10 healthy subjects

Floriano Marchetti, Joseph P. Corallo, Jaime Ritter, Laurence Sands

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

PURPOSE: 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. CONCLUSION: 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.

Original languageEnglish
Pages (from-to)569-573
Number of pages5
JournalJournal of Wound, Ostomy and Continence Nursing
Volume38
Issue number5
DOIs
StatePublished - Sep 1 2011

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Healthy Volunteers
Pressure
Equipment and Supplies
Device Removal
Head
Digital Rectal Examination
Indwelling Catheters
Supine Position
Manometry
Patient Safety
Nuclear Family
Endoscopy
Mucous Membrane

ASJC Scopus subject areas

  • Advanced and Specialized Nursing
  • Medical–Surgical

Cite this

Retention cuff pressure study of 3 indwelling stool management systems : Randomized study of 10 healthy subjects. / Marchetti, Floriano; Corallo, Joseph P.; Ritter, Jaime; Sands, Laurence.

In: Journal of Wound, Ostomy and Continence Nursing, Vol. 38, No. 5, 01.09.2011, p. 569-573.

Research output: Contribution to journalArticle

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abstract = "PURPOSE: 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. CONCLUSION: 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.",
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N2 - PURPOSE: 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. CONCLUSION: 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.

AB - PURPOSE: 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. CONCLUSION: 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.

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