Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty

Study Overview
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Brief Summary
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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.

Official Title
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Goal Directed Fluid Management vs Liberal Fluid Regimen Based on Mean Arterial Pressure in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty: a Randomized, Prospective, Controlled Study.

Conditions
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Hemodynamic Monitoring, Arthroplasty, Replacement, Hip, Anesthesia, Spinal, Crystalloid Solutions

Intervention / Treatment
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* Device: Clearsight non invasive hemodynamic monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 50-80 years ASA I, II or III primary elective hip arthroplasty Exclusion Criteria: spinal anesthesia contraindications periferical vasculopaty other diseases which indicates better an invasive monitoring by radial artery cannulation atrial fibrillation denial or inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clearsight<br>hemodynamic monitoring and goal directed fluid therapy guided by clearsight | Device: Clearsight non invasive hemodynamic monitoring<br>* Goal directed fluid therapy fuided by Clearsight monitoring<br>|
| Other: Control<br>hemodynamic monitoring blinded and silenced, no goal directed fluid therapy. Fluid therapy based on clinical evaluation and mean arterial pressure by non-invasive monitoring | Device: Clearsight non invasive hemodynamic monitoring<br>* Goal directed fluid therapy fuided by Clearsight monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |