NCT05706545

Micro- and Macro-Circulation in Cardiac Surgery Patients

• Status: Suspended
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: IRCCS Policlinico S. Donato · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The hypothesis under the study is that there could be a link between a dysfunction in peripheral microcirculation, sublingual microcirculation or cardiovascular control and the development of post cardiac surgery major morbidities (stroke, acute kidney injury, prolonged intubation, mediastinitis, surgical reopening, death). The state of sublingual microcirculation, of peripheral microcirculation and cardiovascular control will be assessed in 100 patients undergoing cardiac surgery during general anesthesia before the intervention and at the end of the intervention at the arrival in post-surgery ICU by means of signal processing techniques. The extracted markers will be used to assess a statistical prediction model of major morbidities.

Conditions

• Cardiac Surgery
• Coronary Artery Bypass Graft
• Surgical Aortic Valve Replacement

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Acquisition of cardiovascular signals and microcirculation sidestream darkfield images	ECG, arterial pressure and peripheral flow velocity via a percutaneous laser doppler will be acquired together with images of the sublingual microcirculation detected with sidestream darkfield images microscope

Timeline

• Start date: 2027-01-01
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2023-01-31
• Last updated: 2025-03-28

Locations

1 site across 1 country: Italy