Ileus
Conditions
Keywords
Ileus, Abdominal surgery, Bowel obstruction, Postoperative Ileus
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEntac 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.
OTHERPatient 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.
OTHERPatient 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.
Sponsors
Jennifer Hrabe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
All subjects consented and enrolled will receive the same intervention. There is no control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Sensitivity for Predicting Ileus. | Each patient's device's data was assessed at day 15. | 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). |
| Device Specificity for Predicting Ileus | Each patient's device's data was assessed at day 15. | 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). |
| Device Positive Predictive Value for Predicting Ileus | Each patient's device's data was assessed at day 15. | 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). |
| Device Negative Predictive Value for Predicting Ileus | Each patient's device's data was assessed at day 15. | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 203 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Data Corrupt | 6 |
| Overall Study | Device application insufficiant | 3 |
| Overall Study | Device Malfunctioned | 101 |
| Overall Study | Physician Decision | 18 |
Baseline characteristics
| Characteristic | Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 64 Participants |
| Age, Categorical Between 18 and 65 years | 139 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 197 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 195 Participants |
| Region of Enrollment United States | 203 participants |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 203 |
| other Total, other adverse events | 0 / 203 |
| serious Total, serious adverse events | 0 / 203 |
Outcome results
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).
Time frame: Each patient's device's data was assessed at day 15.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Device Negative Predictive Value for Predicting Ileus | Patients with ileus whose device predicted ileus (true positive) | 12 Participants |
| Study Participants | Device Negative Predictive Value for Predicting Ileus | Patients without ileus whose device predicted ileus (false positive) | 22 Participants |
| Study Participants | Device Negative Predictive Value for Predicting Ileus | Patients with ileus whose device did not predict ileus (false negative) | 2 Participants |
| Study Participants | Device Negative Predictive Value for Predicting Ileus | Patients without ileus whose device did not predicted ileus (true negative) | 39 Participants |
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).
Time frame: Each patient's device's data was assessed at day 15.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Device Positive Predictive Value for Predicting Ileus | Patients with ileus whose device predicted ileus (true positive) | 12 Participants |
| Study Participants | Device Positive Predictive Value for Predicting Ileus | Patients with ileus whose device did not predict ileus (false negative) | 2 Participants |
| Study Participants | Device Positive Predictive Value for Predicting Ileus | Patients without ileus whose device predicted ileus (false positive) | 22 Participants |
| Study Participants | Device Positive Predictive Value for Predicting Ileus | Patients without ileus whose device did not predicted ileus (true negative) | 39 Participants |
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).
Time frame: Each patient's device's data was assessed at day 15.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Device Sensitivity for Predicting Ileus. | Patients with Ileus whose device predicted ileus (true positive). | 12 Participants |
| Study Participants | Device Sensitivity for Predicting Ileus. | Patients with ileus whose device did not predict ileus (false negative). | 2 Participants |
| Study Participants | Device Sensitivity for Predicting Ileus. | Patients without ileus whose device predicted ileus (false positive). | 22 Participants |
| Study Participants | Device Sensitivity for Predicting Ileus. | Patients without ileus whose device did not predict ileus (true negative). | 39 Participants |
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).
Time frame: Each patient's device's data was assessed at day 15.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Participants | Device Specificity for Predicting Ileus | Patients without ileus whose device did not predict ileus (true negative) | 39 Participants |
| Study Participants | Device Specificity for Predicting Ileus | Patients with ileus whose device predicted ileus (true positive) | 12 Participants |
| Study Participants | Device Specificity for Predicting Ileus | Patients with ileus whose device did not predict ileus (false negative) | 2 Participants |
| Study Participants | Device Specificity for Predicting Ileus | Patients without ileus whose device predicted ileus (false positive) | 22 Participants |