Preoperative Focused Cardiac Ultrasound in Hip Fracture Surgery (PrEcho)

NCT05862493 | Not Yet Recruiting

• 1 other identifier: Dnr 2022-05628-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Echocardiography; Hip Fractures; Risk Assessment; Anesthesia; Hemodynamic Instability

Keywords

FOCUS; Point-of-care echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change of blood pressure level

  From date of randomization up to 4 hours

• Lowest level of blood pressure (MAP)

  From date of randomization up to 4 hours

• Acute kidney failure

  From date of randomization up to 48 hours

• Myocardial injury

  From date of randomization up to 48 hours

• Readmission

  From date of randomization up to 7 days

Study Arms (2)

Standard management

NO INTERVENTION

Standard preoperative management, no preoperative TTE

FOCUS optimization

EXPERIMENTAL

Standard preoperative management AND preoperative FOCUS along with an individualized hemodynamic optimization based on FOCUS findings.

Diagnostic Test: FOCUS echocardiography

Interventions

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

FOCUS optimization

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umeå University: lead

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Tomi P Myrberg, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomi P Myrberg, MD, PhD

CONTACT

+4692028339; tomi.myrberg@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinded data analysis
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, open label, superiority trial with a 1:1 allocation ratio

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 17, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share