Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001546741
Ethics application status
Approved
Date submitted
5/12/2022
Date registered
14/12/2022
Date last updated
14/06/2023
Date data sharing statement initially provided
14/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of Focused Transthoracic Echocardiography Before Fractured Neck of Femur Surgery on post-operative clinical outcomes in Frail Older People.
Scientific title
Look Before You Leap: Investigating the effect of Focused Transthoracic Echocardiography Before Fractured Neck of Femur Surgery on post-operative clinical outcomes in Frail Older People.
Secondary ID [1] 308548 0
none
Universal Trial Number (UTN)
Trial acronym
ECHONOF-III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip fracture 328405 0
Condition category
Condition code
Injuries and Accidents 325428 325428 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Focused Transthoracic Echocardiography (TTE) in addition to the standard pre-operative evaluation. It is performed before surgery by a doctor (anaesthetist, internal medicine physician, surgeon or cardiologist) proficient in point-of-care ultrasound and trained in the University of Melbourne iHeartScan protocol.
The focused TTE is performed at the bedside of the patient and takes up to 15 minutes to be completed. The test involves a brief assessment of the left and right ventricles' size and function, significant cardiac valve abnormalities (stenosis and regurgitation), presence of pericardial effusion and indirect signs of diastolic left ventricle dysfunction.

A written report will be available to the anaesthetist performing the pre-operative assessment and the medical team involved in the patient care (orthopaedics, ortho- geriatricians and general medicine physicians).

The intervention is delivered in a single time-point (before surgery); therefore, strategies to monitor adherence are not required.
Intervention code [1] 324996 0
Diagnosis / Prognosis
Comparator / control treatment
A standard pre-operative assessment performed by the anaesthetist, which does not include focused transthoracic echocardiography.
This assessment takes around 10 to 15 minutes and involves recollection of the medical history, vital signs (blood pressure, heart rate, respiratory rate and oxygen saturation) and physical examination.
Control group
Active

Outcomes
Primary outcome [1] 333288 0
A composite outcome of the incidence of all-cause mortality, hospital readmission, acute kidney injury, decompensated cardiac failure and myocardial injury in non-cardiac surgery (MINS).
Data will be collected from patient medical records. Measurement of the levels of troponin for the diagnosis of MINS is outside the standard of care and is considered "an investigative test" that will be organised by the research team and collected at baseline, day 1 and day 2 post surgery. Re-admission to the hospital will be collected from the hospital operating system.

All-cause mortality: dichotomous data (yes or not). Death of any cause.

Hospital readmission: dichotomous data (yes or not) of readmission to hospital for any cause.

Acute kidney injury:serum creatinine increase of 1.5-1.9 times from the baseline value in 7 days, or 2 times from baseline value in 1 day or 3 times in 12 hours.

Decompensated cardiac failure: Documented new or worsening symptoms due to heart failure including ONE of the following: dyspnoea, decreased exercise tolerance or fatigue
AND
Objective evidence of new or worsening heart failure consisting in TWO physical examination findings OR ONE physical examination and ONE laboratory criterion.
Physical examination: peripheral oedema, OR pulmonary rales/crackles/crepitations, OR increased jugular venous pressure, OR S3 gallop, OR clinically significant or rapid weight gain thought to be related to fluid retention OR increasing ascites in the absence of primary hepatic disease.
Laboratory findings: BNP greater than 500 pg/mL or NT-proBNP greater than 2000 pg/ml.
OR
Radiological evidence of pulmonary congestion.
OR
Non-invasive diagnostic evidence (E/e’ greater than 15 or plethoric inferior vena cava or decreased ventricular outflow tract minute stroke decreased left ventricular outflow tract (LVOT) minute stroke distance (time velocity integral (TVI))
OR
Invasive diagnostic evidence with right heart catheterization showing a pulmonary capillary wedge pressure (pulmonary artery occlusion pressure) greater or equal to 18 mmHg, central venous pressure greater or equal to 12 mmHg, or a cardiac index less or equal to 2.2 L/min/m2

MINS: Trop greater than 20 ng/L and increase of at least 5 ng/L from the preoperative value, or greater than 65 ng/L regardless the preoperative value.
Timepoint [1] 333288 0
30 day post-surgery
Secondary outcome [1] 416480 0
A composite outcome of the incidence of all-cause mortality, hospital readmission, acute kidney injury, decompensated cardiac failure and myocardial injury in non-cardiac surgery (MINS).
(Definition of each components of the composite outcome is the same used in the primary outcome differing exclusively in the time-point measured)
Data will be collected from patient medical records.
Timepoint [1] 416480 0
1 year post-surgery.
Secondary outcome [2] 416481 0
Incidence of in-hospital respiratory infection: collected from medical records. Documentation of having received antibiotics for a suspected respiratory infection and met one or more of the following criteria: new or changed sputum, new or changed lung opacities, fever, white blood cell count > 12x10/l
Timepoint [2] 416481 0
30 days post-surgery
Secondary outcome [3] 416482 0
Hospital length of stay: obtained from the hospital operating system.
Timepoint [3] 416482 0
30 days post-surgery
Secondary outcome [4] 416483 0
Difference on the clinical frailty scale before surgery versus after surgery.
Timepoint [4] 416483 0
Day 30 and 1 year post-surgery
Secondary outcome [5] 416484 0
Quality of recovery: Proportion of patients returning to their baseline. Will be assessed using the postopQRS survey which can be performed in person or over the phone. Takes 5 minutes.
Timepoint [5] 416484 0
Day 3-5, day 30 and 1 year post-surgery
Secondary outcome [6] 416485 0
Independent living before and after the surgery using the Lawton Brody Instrumental Activities of daily living collected in person and over the phone.
Timepoint [6] 416485 0
Day 30 and 1 year after surgery
Secondary outcome [7] 416486 0
Health cost analysis.
Additional costs of routine focused transthoracic echocardiography will be balanced against other costs due to changes in duration of hospital stay, type of ward, and medical resource consumption due to improved survival.
Data will be collected form the hospital Business Intelligence unit.
Timepoint [7] 416486 0
30 days and 1 year after surgery

Eligibility
Key inclusion criteria
Patients presenting with isolated, primary, non-metastatic fractured neck of femur
surgery is expected within 48 hours after hospital admission
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior hip surgery on the affected side
Likely metastatic cancer
Survival is unlikely in the 24 hours from admission
Having an echocardiography done in the last 30 days

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will be concealed by the web-based enrolment system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated by a computer random sequence generator for each strata of uneven clocks, ensuring close balance of numbers in each group at any time during the trial.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary composite outcome will be compared between groups using a distinct effects generalised estimating equation (GEE) model, specifically, an average relative effect test to determine the common treatment effect across the six components. The heterogeneity of the treatment effects across components will be formally assessed by component interaction test in the GEE. This approach considers the different frequencies of each component, reducing the risk of a single component dominating the composite outcome.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
16/01/2023
Actual
28/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2000
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 23672 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [2] 23673 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 23674 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 23675 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 23676 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [6] 23677 0
Frankston Hospital - Frankston
Recruitment hospital [7] 23678 0
Gosford Hospital - Gosford
Recruitment hospital [8] 23679 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 23680 0
Joondalup Health Campus - Joondalup
Recruitment postcode(s) [1] 39103 0
3050 - Parkville
Recruitment postcode(s) [2] 39104 0
3021 - St Albans
Recruitment postcode(s) [3] 39105 0
2170 - Liverpool
Recruitment postcode(s) [4] 39106 0
5000 - Adelaide
Recruitment postcode(s) [5] 39107 0
3084 - Heidelberg
Recruitment postcode(s) [6] 39108 0
3199 - Frankston
Recruitment postcode(s) [7] 39109 0
2250 - Gosford
Recruitment postcode(s) [8] 39110 0
3168 - Clayton
Recruitment postcode(s) [9] 39111 0
6027 - Joondalup

Funding & Sponsors
Funding source category [1] 312796 0
Government body
Name [1] 312796 0
Department of Health and Aged Care (Medical research future fund)
Country [1] 312796 0
Australia
Primary sponsor type
Hospital
Name
Melbourne health
Address
300 Grattan street
Parkville -Victoria
3050
Country
Australia
Secondary sponsor category [1] 314443 0
None
Name [1] 314443 0
Address [1] 314443 0
Country [1] 314443 0
Other collaborator category [1] 282498 0
University
Name [1] 282498 0
The University of Melbourne
Address [1] 282498 0
Parkville-Victoria
3010
Country [1] 282498 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312083 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 312083 0
Ethics committee country [1] 312083 0
Australia
Date submitted for ethics approval [1] 312083 0
28/02/2022
Approval date [1] 312083 0
29/06/2022
Ethics approval number [1] 312083 0
2022.071

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123410 0
Prof Colin Royse
Address 123410 0
Level 6, Centre for Medical Research, 5 Royal Parade, Parkville, VIC 3050
Country 123410 0
Australia
Phone 123410 0
+61 38344 5673
Fax 123410 0
Email 123410 0
[email protected]
Contact person for public queries
Name 123411 0
Ximena Cid-Serra
Address 123411 0
Level 6, Centre for Medical Research, 5 Royal Parade, Parkville VIC 3050
Country 123411 0
Australia
Phone 123411 0
+61 455532676
Fax 123411 0
Email 123411 0
[email protected]
Contact person for scientific queries
Name 123412 0
Colin Royse
Address 123412 0
Level 6, Centre for Medical Research, 5 Royal Parade, Parkville VIC 3050
Country 123412 0
Australia
Phone 123412 0
+61 38344 5673
Fax 123412 0
Email 123412 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Demographic data and primary outcome.
When will data be available (start and end dates)?
After publication. No end date.
Available to whom?
Investigators with a research project proposal. It will require ethics approval to share.
Available for what types of analyses?
Systematic review with meta-analysis
How or where can data be obtained?
Contacting the principal investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17791Study protocol  [email protected]
17793Informed consent form  [email protected]
17794Ethical approval  [email protected]
17795Statistical analysis plan  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.