Anesthesia, Echocardiography, Hemodynamic Instability, Hip Fractures, Risk Assessment
Conditions
Keywords
FOCUS, Point-of-care echocardiography
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.
Interventions
DIAGNOSTIC_TESTFOCUS echocardiography
Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Blinded data analysis
Intervention model description
This is a randomized, open label, superiority trial with a 1:1 allocation ratio
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Mortality | From date of randomization up to 90 days | Postoperative mortality at 7-, 30- and 90-days |
| Change of blood pressure level | From date of randomization up to 4 hours | Blood pressure (MAP) change from baseline BP |
| Readmission | From date of randomization up to 7 days | Readmission to hospital within 7 days |
| 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 |
| 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 |
| Lowest level of blood pressure (MAP) | From date of randomization up to 4 hours | Absolut lowest blood pressure (MAP) from baseline BP |
Contacts
Primary ContactTomi P Myrberg, MD, PhD
Outcome results
None listed