Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

Anesthesia Clinical Trial

— PrEcho  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05862493
• Other study ID #: Dnr 2022-05628-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 2024
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Umeå University
• Contact: Tomi P Myrberg, MD, PhD
• Phone: +4692028339
• Email: tomi.myrberg[@]umu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Echocardiography
• Fractures, Bone
• Hemodynamic Instability
• Hip Fractures
• Risk Assessment

Intervention

Diagnostic Test:
• FOCUS echocardiography
Preoperative FOCUS echocardiography. Based on FOCUS information: correction of low level of venous return and/or step-up monitoring and/or vasoactive drugs

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of blood pressure level	Blood pressure (MAP) change from baseline BP	From date of randomization up to 4 hours
Secondary	Lowest level of blood pressure (MAP)	Absolut lowest blood pressure (MAP) from baseline BP	From date of randomization up to 4 hours
Secondary	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
Secondary	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
Secondary	Readmission	Readmission to hospital within 7 days	From date of randomization up to 7 days
Secondary	Mortality	Postoperative mortality at 7-, 30- and 90-days	From date of randomization up to 90 days