Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT00307476 |
| Other study ID # |
24200 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2005 |
| Est. completion date |
June 25, 2007 |
Study information
| Verified date |
February 2023 |
| Source |
Christiana Care Health Services |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
