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change in surgical technique (lateral approach vs anterior approach for hip arthroplasty, determining a change in patient intraoperative positioning)
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Patients undergoing elective primary total hip replacement and spinal anesthesia may encounter significant hemodynamic instability.
The study is a randomized controlled type and is aimed at comparing how perioperatory hypotension and fluid regimen are managed using Clearsight non invasive monitoring system or PAM monitoring.
The primary endpoint is to evaluate total duration of hypotension, defined as a MAP < 65 mmHg, calculated during all the perioperatory time.
Fifty-eight patients, aged 50-80 years, with an American Society of Anaesthesiologists' (ASA) score I, II and III were enrolled and split in two groups (Clearsight and control group). Patients were monitored both with the EV1000 platform, the Clearsight finger-cuff and MAP monitoring. Depending on the group, the fluid regimen was a goal directed fluid therapy or a liberal fluid regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clearsight | Experimental | hemodynamic monitoring and goal directed fluid therapy guided by clearsight |
|
| Control | Other | hemodynamic monitoring blinded and silenced, no goal directed fluid therapy. Fluid therapy based on clinical evaluation and mean arterial pressure by non-invasive monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clearsight non invasive hemodynamic monitoring | Device | Goal directed fluid therapy fuided by Clearsight monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| total perioperative hypotension time defined by a mean arterial pressure < 65mmHg, from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room (i.e. up to 8 hours) | from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Bonarelli, MD | Istituto Ortopedico Rizzoli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IORizzoli | Bologna | Italy |
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