Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Echocardiography, Hip Fractures, Risk Assessment, Anesthesia, Hemodynamic Instability

Intervention / Treatment
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* Diagnostic Test: FOCUS echocardiography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized, open label, superiority trial with a 1:1 allocation ratio
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard management<br>Standard preoperative management, no preoperative TTE | |
| Experimental: FOCUS optimization<br>Standard preoperative management AND preoperative FOCUS along with an individualized hemodynamic optimization based on FOCUS findings. | Diagnostic Test: FOCUS echocardiography<br>* Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure drop | Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) < 60 mmHg | From date of randomization up to 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of blood pressure level | Blood pressure (MAP) change from baseline BP | From date of randomization up to 4 hours | 
| Lowest level of blood pressure (MAP) | Absolut lowest blood pressure (MAP) from baseline BP | From date of randomization up to 4 hours | 
| Acute kidney failure | Acute kidney damage defined as a raise in serum creatinine according to the KDIGO-criteria | From date of randomization up to 48 hours | 
| Myocardial injury | 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 | From date of randomization up to 48 hours | 
| Readmission | Readmission to hospital within 7 days | From date of randomization up to 7 days | 
| Mortality | Postoperative mortality at 7-, 30- and 90-days | From date of randomization up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FOCUS, Point-of-care echocardiography