Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

Umeå University

Status: Not yet enrolling

Conditions: Risk Assessment; Hip Fractures; Hemodynamic Instability; Echocardiography; Anesthesia

Treatments: Diagnostic Test: FOCUS echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT05862493

Dnr 2022-05628-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Standard management

No Intervention group

Description:

Standard preoperative management, no preoperative TTE

FOCUS optimization

Experimental group

Description:

Standard preoperative management AND preoperative FOCUS along with an individualized hemodynamic optimization based on FOCUS findings.

Treatment:

Diagnostic Test: FOCUS echocardiography