Clinical trial NCT05862493: Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)
Official title: Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery - Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Echocardiography
Hip Fractures
Risk Assessment
Anesthesia
Hemodynamic Instability
Keywords: FOCUS
Point-of-care echocardiography
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2023-05-17
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, open label, superiority trial with a 1:1 allocation ratio
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Blood pressure drop
timeFrame: From date of randomization up to 4 hours
Secondary outcomes:
measure: Change of blood pressure level
timeFrame: From date of randomization up to 4 hours
measure: Lowest level of blood pressure (MAP)
timeFrame: From date of randomization up to 4 hours
measure: Acute kidney failure
timeFrame: From date of randomization up to 48 hours
measure: Myocardial injury
timeFrame: From date of randomization up to 48 hours
measure: Readmission
timeFrame: From date of randomization up to 7 days
measure: Mortality
timeFrame: From date of randomization up to 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Umeå University
name: Tomi P Myrberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: