Functional hemodynamic monitoring using Continuous Non invasive Arterial Pressure (CNAP) and Capstesia software
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Cardiac Output measured by CNAP/ Capstesia combination
Study Overview
Brief Summary
This is a single blind, prospective, observational, single arm, single centric, cohort study comparing the conventional cardiac output monitor Vigileo TM and IAP (Invasive arterial pressure) combination with the new smartphone based application Capstesia TM and CNAP (Continuous non invasive arterial pressure) combination in 50 consecutive adult patients undergoing major surgery requiring cardiac output monitoring. The primary outcome measure will be cardiac output measured by Capstesia TM at time points 5, 10 , 15, 20, 25, 30, 35, 40 , 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 minutes post surgical incision. The secondary outcome measure would be the Pulse pressure variation (PPV) measured by Capstesia TM at time points 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 minutes post surgical incision.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA physical status II and III 2) Adult patients (
- •75 yrs) of age 3) Either sex 4) Patients with a clinical need for invasive arterial pressure (IAP) monitoring 5) Expected duration of anesthesia > 120 min 6) Body mass index (BMI) between 18.
- •30.0 kg/m2 7) Weight between 45.
Exclusion Criteria
- •Patients with advanced dysfunction of peripheral perfusion (e.g. arterial peripheral artery occlusive disease, Raynaud’s syndrome), arteriovenous shunts for hemodialysis 2) Any history of vascular surgery of the upper extremities 3) History of cardiac arrhythmia 4) Refusal to provide informed consent.
Outcomes
Primary Outcomes
Cardiac Output measured by CNAP/ Capstesia combination
Time Frame: 5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 35 mins, 40 mins, 45 mins, 50 mins, 55 mins, 60 mins, 65 mins, 70 mins, 75 mins, 80 mins, 85 mins, 90 mins, 95 mins, 100 mins, 105 mins, 110 mins, 115 mins, 120 mins
Secondary Outcomes
- Pulse Pressure Variation (PPV) measured by Capstesia(5 mins, 10 mins, 15 mins, 20 mins, 25 mins, 30 mins, 35 mins, 40 mins, 45 mins, 50 mins, 55 mins, 60 mins, 65 mins, 70 mins, 75 mins, 80 mins, 85 mins, 90 mins, 95 mins, 100 mins, 105 mins, 110 mins, 115 mins, 120 mins)