Ignite Creation Date:
2024-05-06 @ 4:28 PM
Last Modification Date:
2024-10-26 @ 2:10 PM
Study NCT ID:
NCT04996420
Status:
TERMINATED
Last Update Posted:
2023-06-01
First Post:
2020-01-29
Brief Title:
Goal Directed Fluid Therapy Versus Liberal Fluid Regimen in Primary Elective Hip Artrhoplasty
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Goal Directed Fluid Management vs Liberal Fluid Regimen Based on Mean Arterial Pressure in Patients Undergoing Spinal Anesthesia for Primary Elective Hip Arthroplasty a Randomized Prospective Controlled Study
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
change in surgical technique lateral approach vs anterior approach for hip arthroplasty determining a change in patient intraoperative positioning
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None