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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04996420
Other study ID # Emospin 2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date May 22, 2019
Est. completion date November 22, 2020

Study information

Verified date July 2021
Source Istituto Ortopedico Rizzoli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 15
Est. completion date November 22, 2020
Est. primary completion date November 22, 2020
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility 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


Intervention

Device:
Clearsight non invasive hemodynamic monitoring
Goal directed fluid therapy fuided by Clearsight monitoring

Locations

Country Name City State
Italy IORizzoli Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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