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Comparison of Rectal Trumpet and Standard Care

NCT00307476 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-02-13

No results posted yet for this study

Summary

Primary: To determine the effectiveness of the rectal trumpet compared to the standard care in maintaining skin integrity in patients with fecal incontinence.

Hypothesis (H1): There will be no difference in the failure rates of rectal area skin integrity between subjects receiving the rectal trumpet and those receiving treatment as usual (staqndard care).

Secondary: To determine the ease of use, cost-effectiveness, and level of patient comfort with the rectal trumpet compared to the standard care in patients with fecal incontinence.

Secondary (exploratory) hypotheses:

There will be differences in the ease of use of the devices, costs of the devices, and patient comfort relative to the devices.

Conditions

  • Fecal Incontinence

Interventions

DEVICE

Rusch Nasopharyngeal Airway

For placement of rectal trumpet (Rusch nasopharyngeal airway-32FR): Patient's skin is cleansed with Smith and Nephew Personal cleanser and rinsed thoroughly with water to remove any soap residue and dried. Apply 3M no sting barrier film to provide skin protectant. Attach the shaft end of the trumpet to a urinary drainage bag. Using hemostats, clamp the tubing beneath the sample port of the drainage bag. Instill 5cc of mineral oil through the flange end of the trumpet, being careful not to over fill or spill mineral oil onto flange. Release the clamp and allow the mineral oil to drain into urinary drainage bag. If possible, place patient into side-lying position with knees drawn toward the chest. Fold flange into quarters, insert into the rectum. Pull back gently until there is slight resistance. Secure the drainage bag to the bed frame. Drainage tubing should be positioned to prevent tension or pull on trumpet.

Sponsors & Collaborators

  • American Association of Critical Care Nurses

    collaborator OTHER

  • Wound Ostomy Continence Nurses Society and Hollister

    collaborator UNKNOWN

  • Christiana Care Health Services

    lead OTHER

Principal Investigators

  • Denise Netta-Turner, BSN · Christiana Care Health Systems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-01
Primary Completion
2007-06-25
Completion
2007-06-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00307476 on ClinicalTrials.gov