NCT02246036

Tolerance and Safety of a Duodenal Probe Monitoring the Microcirculation

Clinical Trial to Assess the Tolerance and the Safety of a Duodenal Tube Monitoring the Microcirculation in 10 Critically Ill Patients.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Advanced Perfusion Diagnostics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

For Intensive Care Units (ICU) patients, Multiple Organ Dysfunction Syndrome (MODS) is a very common complication yielding high morbidity and mortality. Inadequate regional perfusion of certain organs (gut, kidney, liver, etc) often caused by shock is the main cause of MODS. Current practice uses cardiac output data and blood pressure to manage shock but there are still lacks of information about the regional perfusion. This leads to late MODS diagnostics preventing the implementation of adequate treatment. Gut perfusion monitoring seems to be a good target to assess the microcirculation but, nowadays, no practical methods or devices are available to measure the gut perfusion, and the current monitoring methods are not specific (CO, BP, OPS-SDF, PCO2, etc). "MC Monitor" trial is a prospective, multi-center pilot study, enrolling 10 patients. The probe will be used by intensivists on ICU patients with a risk of shock and requiring mechanical ventilation. The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement). This procedure will be used to assess the status of the gut mucosa prior to the placement of the APD probe.

Conditions

• Multiple Organ Dysfunction Syndrome

Interventions

Type	Name	Description
DEVICE	APD probe	The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement).

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-09-01
• Completion: 2016-09-01
• First posted: 2014-09-22
• Last updated: 2016-10-13

Locations

3 sites across 1 country: France