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

NCT04996420 | Terminated

• 1 other identifier: Emospin 2
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Clearsight

EXPERIMENTAL

hemodynamic monitoring and goal directed fluid therapy guided by clearsight

Device: Clearsight non invasive hemodynamic monitoring

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

Device: Clearsight non invasive hemodynamic monitoring

Interventions

Clearsight non invasive hemodynamic monitoring DEVICE

Goal directed fluid therapy fuided by Clearsight monitoring

Clearsight; Control

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50-80 years
• ASA I, II or III
• primary elective hip arthroplasty

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IORizzoli

Bologna, Italy

Location

Study Officials

• Stefano Bonarelli, MD

  Istituto Ortopedico Rizzoli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: August 9, 2021
• Study Start: May 22, 2019
• Primary Completion: November 22, 2020
• Study Completion: November 22, 2020
• Last Updated: June 1, 2023

Record last verified: 2021-07

Locations

IT (1)