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The research proposed in this study will develop a noninvasive prototype device that will capture intestinal sounds, process signals, and display predictive information in real-time at the point-of-care using algorithms already developed at this institution.
Following major abdominal surgery, up to 30% of patients develop a poorly understood condition known as ileus. When ileus occurs, the bowels shut down and patients often develop abdominal dissension, nausea, vomiting, and even more serious complications. Because this condition does not develop until many days after surgery has been completed, clinicians do not know if they should begin allowing patients to eat or withhold nutrition until they show signs of bowel function such as passing gas or having bowel movements. Clinicians have different approaches but none are ideal: 1) feed all patients early and the ones that develop an ileus will have their diets reverse, suction tube placed in their stomach, and hopefully don't get develop more serious complications, or 2) don't feed patients until they pass gas or have a bowel movement, which delays nutrition and prolongs hospital stays for the 70% of patients who will not develop an ileus
Participants in this study will be asked to wear a 3-ounce device that adheres to the skin of the abdominal wall for 10 days. They will also be asked to answer questions each day of their hospital stay regarding how they have tolerated eating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Participants | Experimental | Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entac Medical device application | Device | Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first. |
| Measure | Description | Time Frame |
|---|---|---|
| Device Sensitivity for Predicting Ileus. | Calculate the sensitivity of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with ileus that the device did not predict (true positive + false negative). | Each patient's device's data was assessed at day 15. |
| Device Specificity for Predicting Ileus | Calculate the specificity of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicting no ileus and device incorrectly predicting ileus (true negative plus false positive). | Each patient's device's data was assessed at day 15. |
| Device Positive Predictive Value for Predicting Ileus | Calculate the positive predictive value of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with device incorrectly predicting ileus (true positive plus false positive). | Each patient's device's data was assessed at day 15. |
| Device Negative Predictive Value for Predicting Ileus | Calculate the negative predictive value of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicted no ileus and with ileus the device did not predict (true negative plus false negative). | Each patient's device's data was assessed at day 15. |
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Inclusion Criteria:
Patients undergoing elective intestinal resection surgery by the colorectal surgery service at UIHC.
Age 18 to 100.
Exclusion Criteria:
Allergies to any of the device components. Inability to have prototype device applied to their abdominal wall due to a condition (ie:fistulas, stomas, drains, etc).
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Hrabe | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Participants | Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment Entac Medical device application: Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first. Patient Daily Assessment: The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized. Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment Entac Medical device application: Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first. Patient Daily Assessment: The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized. Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Device Sensitivity for Predicting Ileus. | Calculate the sensitivity of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with ileus that the device did not predict (true positive + false negative). | Posted | Count of Participants | Participants | Each patient's device's data was assessed at day 15. |
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Adverse event data was collected on all subjects until their study participation is completed. (typically at or around 14 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participants | Device: Entac Medical device application Other: Patient Daily Assessment Other: Patient Discharge Assessment Entac Medical device application: Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first. Patient Daily Assessment: The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized. Patient Discharge Assessment: The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Hrabe Clinical Associate Professor | University of Iowa | 319-384-7359 | jennifer-hrabe@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2020 | Nov 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2018 | Nov 25, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D045823 | Ileus |
| D007415 | Intestinal Obstruction |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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All subjects consented and enrolled will receive the same intervention. There is no control group.
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| Patient Daily Assessment | Other | The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized. |
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| Patient Discharge Assessment | Other | The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen. |
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| Device application insufficiant |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Device Specificity for Predicting Ileus | Calculate the specificity of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicting no ileus and device incorrectly predicting ileus (true negative plus false positive). | Posted | Count of Participants | Participants | Each patient's device's data was assessed at day 15. |
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| Primary | Device Positive Predictive Value for Predicting Ileus | Calculate the positive predictive value of the device to predict ileus, as defined by the number of patients with device-predicted ileus (true positive) as compared to the number both with device-predicted ileus and with device incorrectly predicting ileus (true positive plus false positive). | Posted | Count of Participants | Participants | Each patient's device's data was assessed at day 15. |
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| Primary | Device Negative Predictive Value for Predicting Ileus | Calculate the negative predictive value of the device to predict ileus, as defined by the number of patients where the device correctly predicted no ileus (true negative) as compared to the number both with device correctly predicted no ileus and with ileus the device did not predict (true negative plus false negative). | Posted | Count of Participants | Participants | Each patient's device's data was assessed at day 15. |
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| Patients without ileus whose device did not predict ileus (true negative) |
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| Patients without ileus whose device did not predicted ileus (true negative) |
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| Patients without ileus whose device did not predicted ileus (true negative) |
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