An interventional study of Clearsight non invasive hemodynamic monitoring in Arthroplasty, Replacement, Hip, Anesthesia, Spinal and Hemodynamic Monitoring, sponsored by Istituto Ortopedico Rizzoli. Terminated at 1 site in Italy. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by Istituto Ortopedico Rizzoli · Not applicable, Interventional, and Treatment
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.
Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
hemodynamic monitoring and goal directed fluid therapy guided by clearsight
Device: 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
Device: Clearsight non invasive hemodynamic monitoring
Goal directed fluid therapy fuided by Clearsight monitoring
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)
Time frame: from arrival in the anesthesia induction room to resolution of spinal block in Recovery Room
Plan to share: Undecided
No publications or documents are linked to this record.
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Istituto Ortopedico Rizzoli