Comparison of Rectal Trumpet and Standard Care
Comparison of Rectal Trumpet and Standard Care
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.
Method:

 Subjects:

 A convenience sample of 80 adult male and female patients in the Wilmington Intensive Care
 Unit (WICU), Surgical Critical Care Center (SCCC), Medical Intensive Care Unit (MICU), and 6D
 Step-Down, TSU, 5A, 5E/W, will be recruited. After obtaining informed consent, subjects will
 be randomized to one of two groups (experimental: rectal trumpet or standard treatment:
 Hollister fecal incontinent collector).

 Inclusion Criteria: Patients who meet the following criteria:

 1. Diarrhea - two episodes of loose or watery stool in a 12 hour period

 2. ≥ 18 years of age

 3. English-speaking patient or guardian

 4. Intact skin, may be discolored without breakdown

 5. Doctor's order for rectal trumpet (if randomized to treatment group)

 Exclusion Criteria: Patients will be excluded from this study if any of the following are
 present:

 1. prolapsed anal sphincter

 2. active rectal bleeding

 3. colorectal cancer

 4. bleeding precautions

 5. rectal tone rated 1 (gaping) or 2 (lax)

 Instruments:

 The data collection instruments used in this study are investigator-developed (see Appendix A
 - Data Collection Tool). Data will be collected by study and unit nurses at baseline, every
 eight hours, and PRN throughout the duration of the study. Data will have subject
 identification removed and subject number assigned.

 Digital pictures of patients with any identifying marks (e.g., tattoos, birthmarks,
 piercings) will have these marks edited out.

 Procedure:

 A comparison study will be conducted. The staff nurse will identify patients with two or
 greater episodes of loose or watery stool in a 12 hour period and contact study team. Study
 team member will determine if patient meets additional inclusion criteria #2, #3, #4, and #5
 and does not have exclusion criteria #1, #2 or #3. Once this is determined, the study team
 member will approach patient or family for consent to participate in study. After consent is
 obtained, study team member will evaluate patient for remaining exclusion criteria (#4).
 Rectal tone will be assessed and rated by performing a digital rectal exam. If assessed tone
 is rated gaping (1) or lax (2), patient is excluded from study.

 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.

 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.

 Staff will be educated on proper placement of both devices and need for
 reapplication/reinsertion of either device prior to study initiation. Education will be
 provided to staff on the following units: SCCC, MICU, 6DSD, and WICU.

 Study patients will be assessed every 8 hours and PRN for signs of skin breakdown, stool
 leakage around devices, dislodgement, or discomfort from devices using the Numeric Pain
 Intensity Scale for oriented patients. Failure of the fecal incontinent collector will
 include: leakage within 24 hours of application X 2 attempts at placement, or skin breakdown.
 Failure of the rectal trumpet will include: leakage X 2 around trumpet with proper
 positioning within a 24 hour period, skin breakdown, expelling trumpet with continuation of
 diarrhea X 3 in a 24 hour period, or if the oriented patient, when assessed for discomfort
 every 8 hours, rates discomfort 2 points above previous rating level of discomfort or
 requests removal of device due to discomfort.

 Selected digital pictures of patients' skin will be taken to establish inter-rater
 reliability with respect to skin assessment and to provide photographic evidence of skin
 maintenance, healing, or failure with use of either device. A representative from the Medical
 Photography department will instruct investigators on digital photographing of patients'
 skin. Completion of trial will be the return of continence, stool becoming formed, discharge
 from unit of study, or 14 days whichever comes first.
Inclusion Criteria:

 1. Diarrhea - two episodes of loose or watery stool in a 12 hour period

 2. ≥ 18 years of age

 3. English-speaking patient or guardian

 4. Intact skin, may be reddened without breakdown

 5. Doctor's order for rectal trumpet if patient randomized to treatment group

 Exclusion Criteria:

 1. prolapsed anal sphincter

 2. active rectal bleeding

 3. colorectal cancer

 4. bleeding precautions

 5. rectal tone rated 1 (gaping) or 2 (lax)