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NCT07400666
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.
NCT04468698
During pneumoperitoneum insufflation the insufflated gas increase intra-abdominal pressure. The generated pressure can lead to a different increase in volume depending on the abdominal cavity and patients' characteristics. The primary objective is to determine the relationship between intraabdominal pressure (IAP) and intraabdominal volume (IAV) during pneumoperitoneum insufflation. The secondary objective is to determine the rate of abdominal-thoracic transmission (ATT) assessing the correlation between IAP and respiratory driving pressure (ΔPRS).
NCT02520440
The gastrointestinal dysfunction occurs frequently during the intensive care unit (ICU) stay and is associated with a worse prognosis. The gastrointestinal failure (GIF) is diagnosed based on symptoms such as bowel distension, ileus, diarrhea, digestive bleeding, or intestinal ischemia. A GIF score based on has been demonstrated to be correlated with outcome, with higher scores indicating higher risk of death. However, GIF may be occult or clinical signs can go undetected in critically ill patients due to the frequent use of analgesic, sedative or neuromuscular blocking agents, acute neurologic diseases, or delirium. Citrulline is a potential biomarker for small bowel function in critically ill patients with maintained renal function. Normal plasma citrulline levels (12-55 µmol/L) are determined by the balance between gut synthesis and kidney degradation. GIF is involved in the pathogenesis of multiple organ dysfunctions and failures (MOF) through various mechanisms, and it is often associated with high intra-abdominal pressure (IAP). IAP greater than 12 mmHg, may lead to abdominal compartment syndrome (ACS) and MOF, including cardiac, respiratory and kidney failure. Studies have suggested that GIF can be the consequence rather than the cause of MOF. The aim of this study is to investigate if plasma citrulline levels is associated with a clinical diagnosis of GIF, and may predict the development of MOF.