Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188039
Status:
RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-12-13
Brief Title:
Superior Vena Cava Collapsibility Index for Predicting Fluid Responsiveness During High-risk Non-cardiac Surgery
Sponsor:
Uniwersytecki Szpital Kliniczny w Opolu
Organization:
Uniwersytecki Szpital Kliniczny w Opolu
Study Overview
Official Title:
Predicting Fluid REsponsiveness Using Superior Vena Cava Collapsibility IndEx duriNg High-risk Non-Cardiac surgEry PRESCIENCE
Status:
RECRUITING
Status Verified Date:
2024-01
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:
PRESCIENCE
Brief Summary:
The goal of this prospective study is to validate the superior vena cava collapsibility index SVC-CI as a predictor of fluid responsiveness during laparotomy and open aortic surgery The SVC-CI and patients response to fluid will be assessed based on transesophageal echocardiography
The study has three arms in order to validate SVC-CI under the conditions of laparotomy aortic cross clamping and high PEEP levels One of the study arms will be an active comparator arm
The data obtained from this study may help physicians guide intraoperative fluid therapy in a more efficient manner in order to decrease perioperative mortality
The study has three arms in order to validate SVC-CI under the conditions of laparotomy aortic cross clamping and high PEEP levels One of the study arms will be an active comparator arm
The data obtained from this study may help physicians guide intraoperative fluid therapy in a more efficient manner in order to decrease perioperative mortality
Detailed Description:
Patients undergoing high-risk non-cardiac surgery including acute laparotomies and open aortic surgery are at high risk of postoperative complications and adverse cardiovascular events Perioperative fluid therapy is a factor which is strongly associated with postoperative outcomes To avoid both hypovolemia and excessive fluid administration a strategy of goal-directed fluid therapy GDFT has been coined Traditionally in the setting of operating rooms GDFT relied on stroke-volume variation SVV measured by hemodynamic monitors based on uncalibrated pulse contour cardiac output analysis uAPCO However in the described cohort of patients uAPCO methods show a significantly increased measurement error which is mainly attributed to dynamic changes in peripheral vascular tone Furthermore frequent occurrence of arhytmias in those patients limits the use of SVV and all other dynamic indices of fluid responsiveness based on those methods Superior vena cava collapsibility index SVC-CI is a parameter which is devoid of the above mentioned limitations It relies on respiratory variation of superior vena cava during the respiratory cycle and is therefore reliable in patients with irregular heart rhytm and seems independent from changing afterload conditions
The main purpose of this study is to validate SVC-CI in patients undergoing controlled mechanical ventilation during laparotomies and during open aortic surgery with focus on elevated PEEP levels and aortic cross-clamping
The main purpose of this study is to validate SVC-CI in patients undergoing controlled mechanical ventilation during laparotomies and during open aortic surgery with focus on elevated PEEP levels and aortic cross-clamping
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?:
None
Is an FDA AA801 Violation?:
None