Comparison of Rectal Trumpet and Standard Care

NCT00307476 | Withdrawn

• 1 other identifier: 24200
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Fecal Incontinence; Fecal Containment Devices; Skin Integrity

Outcome Measures

Primary Outcomes (1)

• Skin integrity

Secondary Outcomes (3)

• Ease of use

• Cost effectiveness

• Patient comfort

Study Arms (2)

rectal trumpet

ACTIVE COMPARATOR

Patients meeting all study criteria will be randomized to either the rectal trumpet group or the standard treatment. For placement of rectal trumpet (Rusch nasopharyngeal airway-32FR):

Device: Rusch Nasopharyngeal Airway

standard treatment

OTHER

Patients meeting all study criteria will be randomized to either the rectal trumpet group or the standard treatment. The Numeric Pain Intensity Scale (0-10) or staff observation of physiological indicators (e.g., restlessness, sweating, tachycardia, lacrimation, pupil dilatation, poor ventilator synchrony) for disoriented or unresponsive patients will be used prior to and immediately after placement of either device in order to assess patient comfort. Comfort will be assessed every 8 hours on all oriented patients using the Numeric Pain Intensity Scale.

Device: Rusch Nasopharyngeal Airway

Interventions

Rusch Nasopharyngeal Airway DEVICE

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.

rectal trumpet; standard treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diarrhea - two episodes of loose or watery stool in a 12 hour period
• ≥ 18 years of age
• English-speaking patient or guardian
• Intact skin, may be reddened without breakdown
• Doctor's order for rectal trumpet if patient randomized to treatment group

You may not qualify if:

• prolapsed anal sphincter
• active rectal bleeding
• colorectal cancer
• bleeding precautions
• rectal tone rated 1 (gaping) or 2 (lax)

Sponsors & Collaborators

• Christiana Care Health Services: lead
• American Association of Critical Care Nurses: collaborator
• Wound Ostomy Continence Nurses Society and Hollister: collaborator

Study Sites (2)

Christiana Care Health Systems

Newark, Delaware, 19718, United States

Location

Christiana Care Health Systems-Wilmington

Wilmington, Delaware, 19801, United States

Location

MeSH Terms

Conditions

Fecal Incontinence

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Denise Netta-Turner, BSN

  Christiana Care Health Systems

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2006
• First Posted: March 28, 2006
• Study Start: September 1, 2005
• Primary Completion: June 25, 2007
• Study Completion: June 25, 2007
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)