RecruitingACTRN12619000116123

Look before you Leap: A randomized controlled trial of the impact on length of hospital stay of ECHOcardiography Goal-directed Ultrasound Informed Decision-making for Elderly patients undergoing emergency noncardiac surgery - The ECHOGUIDE III trial

Sponsor

Royal Melbourne Hospital

Enrollment

350 participants

Start Date

Jun 3, 2019

Study Type

Interventional

Conditions

Patients aged over 65 years unplanned admission to hospital due to acute illness and scheduled for emergency non-cardiac surgery (thoracic, arterial vascular, general including colorectal and hepatobiliary, ear nose throat, faciomaxillary, neurosurgery and major orthopaedic surgery).

Summary

Emergency surgery is a growing health issue because it is becoming more common and the patients are becoming older and sicker. One month after surgery, one in twenty patients do not survive and one in five patients suffer a major medical issue. One of reasons for this poor outcome is that there is often not enough time for doctor’s to fully evaluate patient’s medical status before emergency surgery. Therefore, the surgery often proceeds without the doctors having a complete medical evaluation of the patient. This can result in errors in treatment and a delay in correct diagnosis, that can result in progression of the disease or harmful treatments. A brief ultrasound examination of the patient has been shown to improve doctor’s medical evaluation of patients before surgery. For example, an ultrasound of the heart may identify a weak heart or blocked valve. In this study we wish to find out whether an ultrasound of the heart, lungs and leg veins results in a better medical outcome and shorter length of hospital stay in patients over 65 years old requiring emergency surgery.

Eligibility

Sex: Both males and femalesMin Age: 66 Yearss

Plain Language Summary

Simplified for easier understanding

Emergency surgery carries significant risks, particularly for older patients. One in twenty patients does not survive the month after emergency surgery, and one in five experiences a major complication. Doctors often have very little time to fully assess a patient's heart and lung condition before emergency operations, which can lead to missed findings and suboptimal management. A brief bedside ultrasound scan — of the heart, lungs, and leg veins — may quickly reveal important information that changes how patients are managed. The ECHOGUIDE III trial tests whether performing this rapid ultrasound assessment before emergency surgery in patients over 65 leads to shorter hospital stays and better outcomes, compared to standard pre-operative assessment without ultrasound. You may be eligible if you are over 65, have been admitted to hospital unexpectedly (due to acute illness, not social reasons), and are scheduled for emergency non-cardiac surgery within 48 hours that is expected to last more than one hour and require at least one night in hospital. Surgery types include general surgery, vascular, orthopaedic, ENT, and neurosurgery. You are not eligible if your surgery is elective, diagnostic, or minimally invasive, or if you are not expected to survive beyond 24 hours.

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Interventions

In addition to standard clinical preoperative evaluation by the treating medical team, participants randomised to the Goal focused ultrasound (GFU) group will receive i) a preoperative focused car

In addition to standard clinical preoperative evaluation by the treating medical team, participants randomised to the Goal focused ultrasound (GFU) group will receive i) a preoperative focused cardiac ultrasound performed prior to surgery, following The University of Melbourne iHeartScan protocol ii) A preoperative lung ultrasound following the The University of Melbourne iLungScan protocol iii) A preoperative femoral and popliteal vein ultrasound using a two-point compression method The clinician who performs the GFU will be qualified to the equivalent of a University Graduate Certificate in Clinical Ultrasound and be trained in the iHeartScan and iLungScan protocol and in deep venous ultrasound. In line with a pragmatic trial, any qualified member of the treating team may perform the GFU, and they will complete a structured research report and report those findings to other team members. The information will be available to all members of the treating team before and after surgery, including surgeons, anaesthetists, intensivists, internal medicine physicians, ortho-geriatricians, and emergency medicine physicians (if the GFU is performed in the emergency department).

Locations(2)

Royal Melbourne Hospital - City campus - Parkville

VIC, Australia

Cape Town, South Africa

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ACTRN12619000116123