The proposed clinical study protocol is intended to establish the safety, utility, and reliability of using a pressure-sensing capsule present in a patient's gastrointestinal tract for monitoring intraabdominal pressure (IAP). Monitoring IAP in critically ill patients is common in patients admitted to the ICU following a wide variety of surgical interventions. It has been reported that approximately 50% of critically ill patients will develop intraabdominal hypertension (IAH; defined as an IAP \>12 mmHg) while in the ICU, which can be life-threatening due to complications resulting from organ dysfunction, organ failure, impaired ventilation and hemodynamic instability. When IAH is persistent and elevated above 20 mmHg the condition is identified as "Abdominal Compartment Syndrome (ACS)", which necessitates close monitoring of patients with IAH in order to reduce the development of ACS. IAP measurements based on technologies employing the bladder, gastric, inferior vena cava, rectal, vaginal and direct intraperitoneal placements have been reported for assessing IAP. However, the gold standard method for monitoring IAP is the use of an intravesical (bladder) Foley catheter manometric technique. PressureDOT® (Dotspace Inc.) is the investigational pressure-sensing capsule that will be assessed in a parallel device clinical study protocol performed in the same patient.
Patients admitted to the ICU who require IAP monitoring.
Are at least 22 years old.
Have a BMI greater than 18.5 kg/m², but less than 35 kg/m².
Expected survival of at least 5 days.
The patient is anticipated to undergo an MRI examination within seven days after ingestion of the capsule.
The patient is anticipated to undergo radiotherapy within seven days after ingestion of the capsule.
Patients who are on ECMO treatment.
Conscious patients with a history of difficulty with swallowing due to functional or anatomic disorder.
Single group
digital capsule
DeviceA digital capsule to monitor intra-gastrointestinal pressure and wirelessly transmit the data to bedside reader for healthcare providers.
Number of participants with treatment-related adverse events as assessed by Clavien-Dindo grade.
The agreements of two IAP measurement devices.
The average time to excrete the PressureDOT digital capsule in the enrolled study participants.
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