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

Istituto Ortopedico Rizzoli

Status: Terminated

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

Treatments: Device: Clearsight non invasive hemodynamic monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04996420

Emospin 2

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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15 participants in 2 patient groups

Clearsight

Experimental group

Description:

hemodynamic monitoring and goal directed fluid therapy guided by clearsight

Treatment:

Device: Clearsight non invasive hemodynamic monitoring

Control

Other group

Description:

hemodynamic monitoring blinded and silenced, no goal directed fluid therapy. Fluid therapy based on clinical evaluation and mean arterial pressure by non-invasive monitoring

Treatment:

Device: Clearsight non invasive hemodynamic monitoring