Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

Not Applicable

Not yet recruiting

• Conditions: Echocardiography; Hip Fractures; Hemodynamic Instability; Risk Assessment; Anesthesia
• Interventions: Diagnostic Test: FOCUS echocardiography

• Registration Number: NCT05862493
• Lead Sponsor: Umeå University

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 (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.

Study Timeline

• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-05-14
• Study First Posted: 2023-05-17
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Study Start: 2024-02
• Primary Completion: 2026-02
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients ≥ 65 years of age, with American Socieity of Anesthesiologists (ASA) physical status classification 2-4, that are scheduled for acute hip fracture surgery (ICD-codes s72.0, s72.00, s72.01, s72.1, s72.2)

Exclusion Criteria

• Metastatic cancer and/or suspect pathological fracture.
• Concurrent other fracture/surgery.
• Reoperation within 72 hours from primary operation.
• Severe dementia.
• Preoperative echocardiography for other reason than participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FOCUS optimization	FOCUS echocardiography	Standard preoperative management AND preoperative FOCUS along with an individualized hemodynamic optimization based on FOCUS findings.

Primary Outcome Measures

Name	Time	Method
Blood pressure drop	From date of randomization up to 4 hours	Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) \< 60 mmHg

Secondary Outcome Measures

Name	Time	Method
Change of blood pressure level	From date of randomization up to 4 hours	Blood pressure (MAP) change from baseline BP
Lowest level of blood pressure (MAP)	From date of randomization up to 4 hours	Absolut lowest blood pressure (MAP) from baseline BP
Readmission	From date of randomization up to 7 days	Readmission to hospital within 7 days
Myocardial injury	From date of randomization up to 48 hours	Myocardial injury defined as a raise in serum high-sensitive troponin with at least 5 ng/l-1 to a minimum concentration of at least 20 ng/l-1
Acute kidney failure	From date of randomization up to 48 hours	Acute kidney damage defined as a raise in serum creatinine according to the KDIGO-criteria
Mortality	From date of randomization up to 90 days	Postoperative mortality at 7-, 30- and 90-days