NCT05862493

Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery - Study Protocol for a Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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 (1:1 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 mmHg.Secondary 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.

Conditions

• Echocardiography
• Hip Fractures
• Risk Assessment
• Anesthesia
• Hemodynamic Instability

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	FOCUS echocardiography	Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-02-01
• Completion: 2026-12-01
• First posted: 2023-05-17
• Last updated: 2023-12-08