Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05862493
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-08
First Post:
2023-04-27
Brief Title:
Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery PrEcho
Sponsor:
Umeå University
Organization:
Umeå University
Study Overview
Official Title:
Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery - Study Protocol for a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
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:
PrEcho
Brief Summary:
The primary objective of this study is to investigate the impact of preoperative focused transthoracic ultrasound FOCUS on intraoperative hypotension and postoperative complications in hip fracture surgery Our hypothesis is that a preoperative FOCUS along with a hemodynamic optimization protocol will reduce the occurrence of intraoperative drops in blood pressure and post-operative complications
Detailed Description:
Hip fracture surgery is a common procedure and despite progress in perioperative management cardiac complications are common and the post-operative mortality remains high In this geriatric patient population cardiac disease as well as varying degrees of dehydration is common and preoperative knowledge of these conditions have a key role in enabling a proactive perioperative hemodynamic management However clinical assessment is surprisingly unreliable and has been shown to easily fail to identify significant cardiac disease and lack of venous return
Transthoracic echocardiography TTE is a well-established and non-invasive investigation that can identify cardiac disease and aberrations in volume status prior to surgery In a preoperative practice the use of focused cardiac ultrasound FOCUS enables an individualized anesthesia management and has been demonstrated to influence anesthesiologist decision making Furthermore measurements of inferior vena cava used as a surrogate for venous return have been shown to be a predictor of intraoperative hypotension
Patients scheduled for daytime hip fracture surgery will be screened for eligibility
Random allocation 11 allocation ratio of patients to receive standard care control group or standard care preoperative focused cardiac ultrasound with a preoperative hemodynamic optimization intervention group Registration of pre- and intraoperative blood pressure as well as post-operative complications and mortality will be conducted
Primary outcome measure Intraoperative hemodynamic instability defined as MAP 60 mmHgSecondary outcome measures Time to surgery length of hospital stay renal failure cardiac complications myocardial ischemia heart failure post-operative atrial fibrillation pulmonary edema pulmonary embolism 7-30- and 90-day mortality
Transthoracic echocardiography TTE is a well-established and non-invasive investigation that can identify cardiac disease and aberrations in volume status prior to surgery In a preoperative practice the use of focused cardiac ultrasound FOCUS enables an individualized anesthesia management and has been demonstrated to influence anesthesiologist decision making Furthermore measurements of inferior vena cava used as a surrogate for venous return have been shown to be a predictor of intraoperative hypotension
Patients scheduled for daytime hip fracture surgery will be screened for eligibility
Random allocation 11 allocation ratio of patients to receive standard care control group or standard care preoperative focused cardiac ultrasound with a preoperative hemodynamic optimization intervention group Registration of pre- and intraoperative blood pressure as well as post-operative complications and mortality will be conducted
Primary outcome measure Intraoperative hemodynamic instability defined as MAP 60 mmHgSecondary outcome measures Time to surgery length of hospital stay renal failure cardiac complications myocardial ischemia heart failure post-operative atrial fibrillation pulmonary edema pulmonary embolism 7-30- and 90-day mortality
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