Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT07253818
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-11-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Passive Leg Raising in Term Pregnancy on Hemodynamic Monitoring - Validating With Transthoracic ECHO (LG-ECHO)
Sponsor:
Ayse Zeynep Turan Civraz
Organization:
Study Overview
Official Title:
Transthoracic Echocardiography as the Reference for Validating Non-invasive Hemodynamic Monitoring During Passive Leg Raising in Term Pregnancy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
(LG-ECHO)
Brief Summary:
This prospective observational validation study aims to evaluate the agreement and diagnostic accuracy of ClearSight™ compared with transthoracic echocardiography (TTE) during PLR in term pregnant women.
The ultimate goal is to determine whether ClearSight™ can reliably identify preload responsiveness in term pregnant women compared with the echocardiographic gold standard. The clinical implication is that, if validated, ClearSight™ may reduce unnecessary or harmful fluid administration by accurately detecting preload reserve, and improve maternal safety in peripartum care by providing obstetric anesthesiologists with reliable bedside monitoring tools.
The ultimate goal is to determine whether ClearSight™ can reliably identify preload responsiveness in term pregnant women compared with the echocardiographic gold standard. The clinical implication is that, if validated, ClearSight™ may reduce unnecessary or harmful fluid administration by accurately detecting preload reserve, and improve maternal safety in peripartum care by providing obstetric anesthesiologists with reliable bedside monitoring tools.
Detailed Description:
Background Pregnancy is characterized by profound hemodynamic changes, which complicate perioperative monitoring and fluid therapy. Non-invasive cardiac output monitoring device, ClearSight™ system, provides continuous stroke volume estimates, but their reliability in pregnant women remains uncertain. Passive leg raising (PLR) is a reversible preload test that can elucidate fluid responsiveness without fluid administration. To date, no study has simultaneously validated ClearSight™ against echocardiographic reference standards during PLR in term pregnant women.
Methods This is a prospective, single-centre, method-comparison and diagnostic accuracy study in term pregnant women (≥37 weeks). Simultaneous ClearSight™ and transthoracic echocardiography (TTE) measurements will be obtained at baseline, during PLR, and during recovery. The primary outcome is agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR. Secondary outcomes include trending ability and diagnostic accuracy of ClearSight™ Δ%SVI for detecting PLR responders. Four-quadrant and polar plot analyses are the parameters for advanced hemodynamic monitoring methods used in echocardiography to assess fluid responsiveness and cardiac output (CO) trending Sample size: 60 participants, providing at least 180 paired observations.
Conclusions This study will establish whether ClearSight™ can reliably detect preload responsiveness in term pregnant women. Findings could support safer, real-time, non-invasive hemodynamic management during obstetric anaesthesia and maternal critical care.
Methods This is a prospective, single-centre, method-comparison and diagnostic accuracy study in term pregnant women (≥37 weeks). Simultaneous ClearSight™ and transthoracic echocardiography (TTE) measurements will be obtained at baseline, during PLR, and during recovery. The primary outcome is agreement between ClearSight™-derived stroke volume index (SVI) changes and TTE-derived Left Ventricular Outflow Tract - Velocity Time Integral (LVOT-VTI) changes during PLR. Secondary outcomes include trending ability and diagnostic accuracy of ClearSight™ Δ%SVI for detecting PLR responders. Four-quadrant and polar plot analyses are the parameters for advanced hemodynamic monitoring methods used in echocardiography to assess fluid responsiveness and cardiac output (CO) trending Sample size: 60 participants, providing at least 180 paired observations.
Conclusions This study will establish whether ClearSight™ can reliably detect preload responsiveness in term pregnant women. Findings could support safer, real-time, non-invasive hemodynamic management during obstetric anaesthesia and maternal critical care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: