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

NCT ID: NCT04996420

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-22
• Study Completion Date: 2020-11-22

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clearsight

hemodynamic monitoring and goal directed fluid therapy guided by clearsight

Group Type: EXPERIMENTAL

Clearsight non invasive hemodynamic monitoring

Intervention Type: DEVICE

Goal directed fluid therapy fuided by Clearsight monitoring

Control

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

Group Type: OTHER

Clearsight non invasive hemodynamic monitoring

Intervention Type: DEVICE

Goal directed fluid therapy fuided by Clearsight monitoring

Interventions

Clearsight non invasive hemodynamic monitoring

Goal directed fluid therapy fuided by Clearsight monitoring

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefano Bonarelli, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Ortopedico Rizzoli

Locations

IORizzoli

Bologna, , Italy

Countries

Italy

Other Identifiers

Emospin 2

Identifier Type: -

Identifier Source: org_study_id