Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000227998
Ethics application status
Approved
Date submitted
9/02/2011
Date registered
2/03/2011
Date last updated
3/03/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial to determine whether anaesthetist-performed
preoperative transthoracic echocardiography improves the quality of recovery of patients undergoing fractured neck of femur surgery.
Scientific title
A randomised trial to determine whether anaesthetist-performed
preoperative transthoracic echocardiography (intervention) improves the quality of recovery of patients (PQRS assessment) aged over 65 years who undergo fractured neck of femur surgery.
Secondary ID [1] 252909 0
NIL
Universal Trial Number (UTN)
Trial acronym
ECHONOF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative recovery from fractured neck of femur surgery 261132 0
Condition category
Condition code
Anaesthesiology 259285 259285 0 0
Anaesthetics
Injuries and Accidents 259286 259286 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Anaesthetist performed limited transthoracic echocardiography (TTE) on prior to surgery.
a)approximate duration 20 minutes (including report)
b)on the same day of surgery
Intervention code [1] 258004 0
Diagnosis / Prognosis
Comparator / control treatment
Controls will get standard clinical assessment of cardiovascular function by the anaesthetist without TTE.
This is a routine assessment done by all anaesthetists on every patient prior to their anaesthesia (for all types of procedures including fractured neck of femur surgery). This assessment is not defined as every anaesthetist has their own method which is tailored to each individual patient (which depends on the patients health and the planned procedure). Subjects from both groups receive a standard cardiovascular examination by the anaesthetist but the TTE group receive a TTE and the control group do not. The TTE provides more accurate diagnostic information on the cardiovascular health of the patient.
Control group
Active

Outcomes
Primary outcome [1] 262097 0
Postoperative quality of recovery score (PQRS) 20% greater in the TTE group compared with controls.
Timepoint [1] 262097 0
3 days after surgery.
Secondary outcome [1] 273150 0
mortality
Timepoint [1] 273150 0
3 months after surgery.

Eligibility
Key inclusion criteria
-scheduled for isolated fractured neck of femur surgery (i.e. no additional surgical operations)
-informed consent from the patient
-able to complete the PQRS testing (requires sufficient English Language and cognitive skills).
Minimum age
66 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no consent
Documented:
-TTE, stress TTE, cardiac MRI, TOE or documented cardiology consultation within the past 6 months,
-additional surgical procedures to be performed at the same time as the neck of femur,
-if the responsible anaesthetist insists on a TTE prior to surgery.
-Coronary perfusion imaging and coronary or left ventricular angiography do not necessitate exclusion from enrolment.

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)
Patients entered onto the emergency surgery list will be screened by research nurses. Suitable subjects will be confirmed with one of the primary investigators. Randomisation will be by opaque sealed envelopes produced by a non-study participant
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by opaque sealed envelopes produced by a non-study participant, and the randomisation sequence will be generated using a computer random sequence generator. The randomisation code will only be issued prior to the commencement of surgery and will be known only to the treating anaesthetist.
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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258465 0
University
Name [1] 258465 0
The University of Melbourne
Country [1] 258465 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Department of Pharmacology, University of Melbourne
245 Cardigan Street, Carlton, Victoria, 3053
Country
Australia
Secondary sponsor category [1] 257606 0
Charities/Societies/Foundations
Name [1] 257606 0
Australian and New Zealand COllege of Anaesthetists
Address [1] 257606 0
ANZCA House
630 St Kilda Road
Melbourne
Vic 3004.
Country [1] 257606 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260445 0
MELBOURNE HEALTH HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [1] 260445 0
Royal Melbourne Hospital
Grattan street
Parkville Victoria 3050
Ethics committee country [1] 260445 0
Australia
Date submitted for ethics approval [1] 260445 0
Approval date [1] 260445 0
27/01/2011
Ethics approval number [1] 260445 0
2010.251

Summary
Brief summary
This study aims to investigate the impact of anaesthetist-performed transthoracic echocardiography (TTE) on the quality of recovery of patients undergoing fractured neck of femur surgery.
It also aims to collect data to determine if a future trail investigating whether or not TTE reduces patient mortality after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31800 0
Address 31800 0
Country 31800 0
Phone 31800 0
Fax 31800 0
Email 31800 0
Contact person for public queries
Name 15047 0
Dr David Canty
Address 15047 0
Department of Pharmacology, University of Melbourne
245 Cardigan Street, Carlton, Victoria, 3053
Country 15047 0
Australia
Phone 15047 0
+61(0)448906793
Fax 15047 0
Email 15047 0
[email protected]
Contact person for scientific queries
Name 5975 0
Dr David Canty
Address 5975 0
Department of Pharmacology, University of Melbourne
245 Cardigan Street, Carlton, Victoria, 3053
Country 5975 0
Australia
Phone 5975 0
0448906793
Fax 5975 0
Email 5975 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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