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Trial registered on ANZCTR


Registration number
ACTRN12616001472460
Ethics application status
Approved
Date submitted
19/10/2016
Date registered
24/10/2016
Date last updated
5/09/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Retrospective Review of Intra-operative Anaesthesia Management during Fractured Neck of Femur (IAM-NOF) Surgery and Mortality
Scientific title
A Retrospective Review of Intra-operative Anaesthesia Management during Fractured Neck of Femur (IAM-NOF) Surgery and Mortality
Secondary ID [1] 290351 0
None
Universal Trial Number (UTN)
Trial acronym
IAM-NOF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fractured Neck of Femur 300640 0
Condition category
Condition code
Surgery 300484 300484 0 0
Other surgery
Anaesthesiology 300485 300485 0 0
Anaesthetics
Injuries and Accidents 300501 300501 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective study of the influence of intra-operative blood pressure management and depth of anaesthesia on mortality after fractured neck of femur (NOF) surgery.
This study will review the medical, surgical, and anaesthesia records of patients admitted for NOF surgery in a 4 year period (2012 – 2016) in Liverpool Hospital. Relevant anaesthesia data, such as blood pressure pre- and intra-operatively, as well as depth of anaesthesia levels, will be collected. NOF patients will be identified through the Department of Orthopaedics database of surgical operations records for the same period. The database records 30- and 120-day mortality. The data from both medical records and the NOF database will be cross-referenced and combined, to allow researchers to analyse the impact of anaesthesia management on post-operative mortality.
Intervention code [1] 296167 0
Diagnosis / Prognosis
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 299914 0
The primary outcome of this study is to determine if intra-operative MAP is associated with 30- and 120-day mortality in patients undergoing fractured NOF surgery. MAP is measured non-invasively or invasively as routine during anaesthesia and data extracted from the anaesthesia record. Mortality data is extracted from the NOF surgery audit maintained by the Department of Orthopaedics, Liverpool Hospital.
Timepoint [1] 299914 0
30-days and 120-days after surgery
Secondary outcome [1] 328512 0
The secondary outcome of this study is to determine if intra-operative depth of anaesthesia is associated with 30- and 120-day mortality in patients undergoing fracture NOF surgery. Depth of anaesthesia is measured as a dimensionless scale from 0 to 100. This data is retrieved from the anaesthesia record. Mortality data is extracted from the NOF surgery audit maintained by the Department of Orthopaedics, Liverpool Hospital.
Timepoint [1] 328512 0
30- and 120-days after surgery

Eligibility
Key inclusion criteria
Adult patients, >50 years old, admitted for emergency fractured NOF surgery in the 4 year time period, June 01 2012 - June 30, 2016
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted for NOF but not offered surgery

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Sample size calculation
From White et al's study, there was a 4.5% mortality rate at 30-days for patients with MAP 71-75mmHg, versus 1.1% for those with higher MAP (White et al, Secondary analysis of outcomes after 11,085 hip fracture operations from the prospective UK Anaesthesia Sprint Audit of Practice. Anaesthesia 2016. 71:506). With an a priori calculated effect size of 0.16, we estimate that a sample size of 954 patients is required to detect a difference in mortality with a significance of 0.05, and power of 0.80. As there are approximately 250 NOF surgeries per year at Liverpool Hospital, a four year retrospective period of data collection will be sufficient for analysis of the primary outcome. A recent period was chosen as anaesthesia management would be relatively unchanged.

Statistical analysis
T-tests, Mann-Whitney U tests, and Fisher's exact tests, as appropriate, will be used to compare patient characteristics to mortality at 30- and 120-days. Patients will be stratified into 3 cohorts based on excursion of intra-operative MAP below their pre-surgery MAP, defined as: tight (<= 12% below pre-surgery), intermediate (13 – 24% below pre-surgery), and loose (>= 25% below pre-surgery). Assuming a pre-surgery MAP of 90mmHg, these cohorts correspond to intra-operative MAP bands of 79 – 90mmHg (tight control), 68 – 78mmHg (intermediate control), and <= 67mmHg (loose control), which are clinically relevant values. For the primary outcome, cohorts will be analysed against 30- and 120-day mortality using Cochran-Mantel-Haenszel tests for repeated tests of independence.
Depth of anaesthesia is measured as a dimensionless scale from 0 to 100. For the secondary outcome, depth of anaesthesia will be analysed against 30- and 120-day mortality using the t-test or Wilcoxon signed-rank test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2017
Actual
1/02/2017
Date of last participant enrolment
Anticipated
1/12/2017
Actual
11/06/2018
Date of last data collection
Anticipated
Actual
11/06/2018
Sample size
Target
954
Accrual to date
Final
1008
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 6841 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 14506 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 294735 0
Hospital
Name [1] 294735 0
Department of Anaesthesia, Liverpool Hospital
Country [1] 294735 0
Australia
Primary sponsor type
Individual
Name
Dr Alwin Chuan
Address
Department of Anaesthesia
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth St
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 293583 0
None
Name [1] 293583 0
Address [1] 293583 0
Country [1] 293583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296153 0
South West Sydney HREC
Ethics committee address [1] 296153 0
Ethics committee country [1] 296153 0
Australia
Date submitted for ethics approval [1] 296153 0
01/11/2016
Approval date [1] 296153 0
07/12/2016
Ethics approval number [1] 296153 0

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

Contacts
Principal investigator
Name 69774 0
Dr Alwin Chuan
Address 69774 0
Department of Anaesthesia
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth St
Liverpool NSW 2170
Country 69774 0
Australia
Phone 69774 0
+61 2 9828 3173
Fax 69774 0
Email 69774 0
[email protected]
Contact person for public queries
Name 69775 0
Alwin Chuan
Address 69775 0
Department of Anaesthesia
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth St
Liverpool NSW 2170
Country 69775 0
Australia
Phone 69775 0
+61 2 9828 3173
Fax 69775 0
Email 69775 0
[email protected]
Contact person for scientific queries
Name 69776 0
Alwin Chuan
Address 69776 0
Department of Anaesthesia
Level 1, New Clinical Building
Liverpool Hospital
Elizabeth St
Liverpool NSW 2170
Country 69776 0
Australia
Phone 69776 0
+61 2 9828 3173
Fax 69776 0
Email 69776 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
No documents have been uploaded by study researchers.

Documents added automatically
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