Intra-Abdominal Hypertension
Conditions
Keywords
Intra-Abdominal hypertension, Intravesical pressure, Intra-gastrointestinal monitoring device, laparoscopic surgery, Abdominal compartment Syndrome
Brief summary
PDT is a continuous pressure monitoring for Intra-Abdominal hypertension (IAH) designed to be less invasive than pan-endoscopic evaluation, more tolerable than abdominal tapping, and more effective than intravesical pressure measurement for IAH. The PDT device consists of a piezoelectric sensor module with a low power Bluetooth wireless transmitter encased in biocompatible capsule. The device will be swallowed after activation. Following PDT insertion, the patient is fitted with a custom, removable external waist accessory containing a receiver, which is worn during monitoring and provide PDT location by signal analysis with sufficient information to provide IAH trends.
Detailed description
The participant will receive first phantom capsule after complete survey before the test, which include standard clinical intra-vesical pressure measurement in the perioperative period of laparoscopic surgery. The phantom capsule is an equal-weighted device of the same outer shell but without the electric circuits. After the phantom capsule has been passed out, the participant will receive the standard PDT capsule to record measured information continuously. The date of the laparoscopic surgery should be within follow-up day 2 to day 6. Standard clinical intra-vesical pressure measurement will only be applied in the perioperative period of laparoscopic surgery. The participant will still be monitored by standard PDT capsule afterwards. After the PDT capsule passed out, the participant will receive complete checkup again for comparison.
Interventions
DEVICEIntra-gastrointestinal monitoring device (PDT)
The PressureDOT(PDT) is an active intra-gastrointestinal device, that is intended to be introduced in the gastrointestinal tract, approximately along whole. The device is battery powered. The signal is wirelessly transmitted through outside the body and received by waist receiver, using an antenna array applied to the skin with a protection guard at the level of the abdomen.
Sponsors
DOTSPACE
Chang Gung Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Patient volunteer planning for laparoscopic surgery * Subjects willing to sign an informed consent form (ICF), * Adult subjects, age ≥ 20 and age ≤ 80 years old * BMI between 15（kg/m2）- 35（kg/m2） * Subjects willing to comply to study protocol requirements (blood pressure measurement, diet, alcohol, study visits, blood sampling, etc.) * Patient who had been scheduled for any laparoscopic surgery which may alter intra-abdominal pressure. * Patient volunteer planning for laparoscopic surgery, as self-declared and confirmed by screening assessments and Principal Investigator's judgment
Exclusion criteria
* Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation), * Any evidence that occlusion of gastrointestinal tract is obvious or severe paralytic ileus that may result in intra-abdominal hypertension in need of immediate surgical intervention not caused by base of tongue (i.e., central apnea, neurologic disorder, retropalatal collapse, nasal obstruction) * Any condition that subject is expected to undergo MRI examination within 7 days after ingestion of the capsule. * Any factor that, in the surgeon's judgment, would pose a risk to surgery or placement of an intra-gastrointestinal monitoring device * Any factor that, in the surgeon's judgment, would make the subject unlikely to respond to PDT insertion and pressure measurement. * Congenital anomalies of gastrointestinal tract or any other anatomical abnormality of the head, neck, chest, or abdomen that would be a contraindication to placement of the PDT device and usage of the external device * There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of device-related or sensor insertion/removal procedure-related adverse events | 15 days | evaluating of incidence of adverse event (AE) |
| Rate of foreign body reaction due intra-gastrointestinal insertion | 15 days | evaluating GI symptoms |
| Rate of GI symptoms, i.e. inflammation, infection, diarrhea, bowel obstruction, and ileus | 15 days | evaluating safety |
| Incidence of sensor failure | 15 days | evaluating stability of device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of GI dysfunction after 10 days post explantation of the PDT sensor. Follow-up via phone call after 30 days | 30 days | monitoring of GI symptoms |
| Duration of PDT insertion and explantation procedure | 15 days | monitoring usability needs |
| Incidence of side effects in Post explantation follow-up | 30 days | follow up for sequel |
| Percentage of users feedback in the form of clinical questionnaire to assess the 'easiness' of insertion procedure with questionnaire | 1 day | evaluating feed back |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of influence of interference substances (i.e. water, saliva, gastric juice, bile, intestinal secretion, feces, and food debris ) | 7 days | evaluating feasibility of working condition |
| Rate of sensor ability to measure intra-gastrointestinal pressure (IGP) to allow the development of the algorithm | 5 days | workup for correlation |
Countries
Taiwan
Contacts
Primary ContactDong-Ru Ho, MD, PhD
Outcome results
None listed