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

Not Applicable

Terminated

• Conditions: Arthroplasty, Replacement, Hip; Anesthesia, Spinal; Hemodynamic Monitoring; Crystalloid Solutions
• Interventions: Device: Clearsight non invasive hemodynamic monitoring

• Registration Number: NCT04996420
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-22
• Study First Submitted: 2020-01-29
• Primary Completion: 2020-11-22
• Study Completion: 2020-11-22
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-09
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-06-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clearsight	Clearsight non invasive hemodynamic monitoring	hemodynamic monitoring and goal directed fluid therapy guided by clearsight
Control	Clearsight non invasive hemodynamic monitoring	hemodynamic monitoring blinded and silenced, no goal directed fluid therapy. Fluid therapy based on clinical evaluation and mean arterial pressure by non-invasive monitoring

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IORizzoli; 🇮🇹 Bologna, Italy