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NCT Number: NCT05862493

Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FOCUS echocardiography

Diagnostic Test

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

Primary outcomes

  1. Blood pressure drop

    Time frame: From date of randomization up to 4 hours

    Intraoperative drop in blood pressure defined as mean arterial pressure (MAP) < 60 mmHg

Secondary outcomes

  1. Change of blood pressure level

    Time frame: From date of randomization up to 4 hours

    Blood pressure (MAP) change from baseline BP

  2. Lowest level of blood pressure (MAP)

    Time frame: From date of randomization up to 4 hours

    Absolut lowest blood pressure (MAP) from baseline BP

  3. Acute kidney failure

    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

  4. Myocardial injury

    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

  5. Readmission

    Time frame: From date of randomization up to 7 days

    Readmission to hospital within 7 days

  6. Mortality

    Time frame: From date of randomization up to 90 days

    Postoperative mortality at 7-, 30- and 90-days

Study contacts

Contact information is provided by the study sponsor or research team.

Tomi P Myrberg, MD, PhD

CONTACT

[email protected]

+4692028339

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Acronym: PrEcho

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
May 17, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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