Micro- and Macro-Circulation in Cardiac Surgery Patients
- Conditions
- Cardiac SurgeryCoronary Artery Bypass GraftSurgical Aortic Valve Replacement
- Registration Number
- NCT05706545
- Lead Sponsor
- IRCCS Policlinico S. Donato
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 100
- age >18 yrs
- indication for a cardiac surgery intervention
- spontaneous sinus rhythm
- informed consent
- know autonomic nervous systems pathologies or dysfunctions
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prediction of major morbidities by means of the variability of cardiovascular and hemodynamics markers 24 months Statistical model assessment; time series variability analysis
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IRCCS Policlinico San Donato
🇮🇹San Donato Milanese, Milan, Italy