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Trial of Focused Cardiac Ultrasound for Fractured Neck of Femur Surgery (ECHONOFII)

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ClinicalTrials.gov Identifier: NCT02629484
Recruitment Status : Completed
First Posted : December 14, 2015
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Melbourne Health
Austin Health
Information provided by (Responsible Party):
Colin Royse, University of Melbourne

Brief Summary:
Hip fracture surgery is a major world health care burden and concern, as it has a large and increasing prevalence and carries very high patient mortality, disability and community health care cost. As the commonest cause of mortality is from cardiac complications, and cardiac disease is prevalent and frequently missed by standard care, we hypothesise that earlier and more accurate diagnosis and treatment of cardiac pathology in this cohort will lead to improved outcome. Focused cardiac ultrasound (FCU) is a new increasingly popular technique used by doctors that enables earlier and more accurate diagnosis of cardiac disorders that can be performed routinely before hip fracture surgery. Our preliminary data of 64 patients demonstrated that routine FCU before surgery lead to a change in cardiac diagnosis and management in 50% of patients requiring hip fracture surgery, which was associated with a 50% reduction in mortality 12 months after surgery compared with controls. It is therefore important for a large randomised trial to be performed to confirm or rebuke these findings, as if true, would have a very large impact on health care and may also improve health care and outcome in other high-risk surgical populations. The proposed pilot study is a pilot study which aims to establish feasibility, safety, compliance and group separation prior to commencing a definitive multicentre trial.

Condition or disease Intervention/treatment Phase
Hip Fractures Other: Focused cardiac ultrasound Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Assess Feasibility, Compliance, Safety and Group Separation for a Multicentre Randomised Trial of Preoperative Focused Cardiac Ultrasound for Fractured Neck of Femur Surgery
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : January 26, 2017
Actual Study Completion Date : January 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Focused Cardiac Ultrasound
participants randomised to receive focused cardiac ultrasound prior to surgery for hip fracture
Other: Focused cardiac ultrasound
focused cardiac ultrasound is a goal-focused transthoracic echocardiography examination of the heart, aimed to improve the diagnostic accuracy of clinical assessment

No Intervention: Standard care (clinical assessment)
Participants randomised to standard care receive clinical assessment of the patient



Primary Outcome Measures :
  1. Composite mortality and morbidity score [ Time Frame: 30 days after surgery ]
    The primary outcome is 30 day composite outcome of the incidence of mortality, acute kidney injury, and cardiovascular morbidity (including non-fatal myocardial infarction, stroke, pulmonary embolism or cardiac arrest.


Secondary Outcome Measures :
  1. The number of days alive, out of hospital, and until return to place of origin [ Time Frame: 12 months ]
    Longitudinal measures include the number of days alive, out of hospital and returning to their place of origin out to 12 months.

  2. Changes in clinician diagnosis and management from a recorded preoperative plan [ Time Frame: 30 days ]
    The treating doctors will complete a diagnosis and management research form prior to revealing the FCU findings or not. The actual management of the patient after allocation will be recorded prospectively for all patients, with the data recording sheets not showing allocation. Data include cardiac monitoring and treatment preoperatively, intraoperatively and postoperatively, including type of anaesthesia, fluid therapy, inotropes, other invasive organ support and intensive care use, surgical technique, and additional cardiovascular management post-hospital discharge.

  3. Total cost of care [ Time Frame: 12 months ]
    Units of health care resources consumed will be combined with Australian unit costs derived from Pharmaceutical benefit schedule, Medicare and Australian Diagnostic group indicators. The dollar value for each component of stay (e.g. days in hospital, drugs used, investigations performed) will be converted into a cost value and aggregated to make a single cost over the 12 month follow up period

  4. EuroQol Health status score [ Time Frame: 12 months ]
    The EuroQol health status survey instrument is a a standard, internationally validated instrument with Australian population norms, will be conducted at 12 months follow up



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting with isolated, primary, non-metastatic fractured neck of femur, where surgery is expected within 48 hours after hospital admission will be recruited.

Exclusion Criteria:

  • Patients with prior hip surgery on the affected side, or where the cause is likely to be due to metastatic cancer, or where survival is unlikely in the 24 hours from admission will not be included.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02629484


Locations
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Australia, Queensland
Prince Charles Hospital
Brisbane, Queensland, Australia
Australia, Victoria
Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050
Western and Sunshine General hospitals
Melbourne, Victoria, Australia
Sponsors and Collaborators
University of Melbourne
Melbourne Health
Austin Health
Investigators
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Principal Investigator: Colin Royse, MD, BS University of Melbourne

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Responsible Party: Colin Royse, Professor of Anaesthesia, University of Melbourne
ClinicalTrials.gov Identifier: NCT02629484     History of Changes
Other Study ID Numbers: 2015.231
First Posted: December 14, 2015    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2018

Keywords provided by Colin Royse, University of Melbourne:
echocardiography
hip fracture
surgery
outcomes

Additional relevant MeSH terms:
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Hip Fractures
Femoral Neck Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Hip Injuries
Leg Injuries