FOCUS echocardiography
Diagnostic TestPreoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs
NCT Number: NCT05862493
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs
Time frame: From date of randomization up to 4 hours
Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) < 60 mmHg
Time frame: From date of randomization up to 4 hours
Blood pressure (MAP) change from baseline BP
Time frame: From date of randomization up to 4 hours
Absolut lowest blood pressure (MAP) from baseline BP
Time frame: From date of randomization up to 48 hours
Acute kidney damage defined as a raise in serum creatinine according to the KDIGO-criteria
Time frame: 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
Time frame: From date of randomization up to 7 days
Readmission to hospital within 7 days
Time frame: From date of randomization up to 90 days
Postoperative mortality at 7-, 30- and 90-days
Contact information is provided by the study sponsor or research team.
Umeå University
Other
Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery - Study Protocol for a Randomized Controlled Trial
Acronym: PrEcho
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