Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000336189p
Ethics application status
Not yet submitted
Date submitted
23/02/2019
Date registered
5/03/2019
Date last updated
5/03/2019
Date data sharing statement initially provided
5/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective observational study exploring association between Fractured Neck of Femur (#NOFF) patient's cardiovascular state and postoperative brain oxygen levels and mental state
Scientific title
NIRFlo-NOFF: A prospective observational study exploring association between CI (Cardiac Index) and postoperative cerebral oxygenation and cognition, in the #NOFF (Fractured [#] Neck of Femur) population
Secondary ID [1] 297512 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative delirium 311711 0
postoperative cerebral oxygenation 311712 0
Intraoperative haemodynamic change 311713 0
intraoperative cerebral oxygenation 311714 0
#NOFF (Fractured Neck of Femur) 311816 0
Condition category
Condition code
Anaesthesiology 310331 310331 0 0
Other anaesthesiology
Neurological 310422 310422 0 0
Other neurological disorders
Surgery 310423 310423 0 0
Other surgery
Musculoskeletal 310424 310424 0 0
Other muscular and skeletal disorders
Injuries and Accidents 310453 310453 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Use of intraoperative semi-invasive cardiac index monitoring to examine for episodes of reduced cardiac index; and intraoperative cerebral oxygenation monitoring to examine for episodes of reduced cerebral oxygen levels; then use of postoperative cerebral oxygenation monitoring to examine for episodes of reduced cerebral oxygen levels in the postoperative Day 1-5 period, in the surgical Fractured NOFF population
Intervention code [1] 313750 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319213 0
Episodes of low intraoperative CI associated with episodes of low postoperative NIRS (cerebral oxygenation). This will be assessed by quantifying duration of intraoperative times of recorded low CI by flotrac CI monitoring and the occurrence of low postoperative NIRS readings by bihemispheric cerebral oxygenation monitoring during postoperative days 1 to 5
Timepoint [1] 319213 0
Postoperative Days 1 to 5
Secondary outcome [1] 367322 0
Episodes of low MAP as measured by flotrac cardiac output and continuous invasive arterial blood pressure monitoring intraoperatively
Timepoint [1] 367322 0
Intraoperative time
Secondary outcome [2] 367566 0
Episodes of low SV as measured by flotrac cardiac output and continuous invasive arterial blood pressure monitoring intraoperatively
Timepoint [2] 367566 0
Intraoperative time
Secondary outcome [3] 367567 0
Episodes of low SVV as measured by flotrac cardiac output and continuous invasive arterial blood pressure monitoring intraoperatively
Timepoint [3] 367567 0
intraoperative time
Secondary outcome [4] 367568 0
Episodes of low SVR as measured by flotrac cardiac output and continuous invasive arterial blood pressure monitoring intraoperatively
Timepoint [4] 367568 0
intraoperative time
Secondary outcome [5] 367569 0
Duration of MAP <70 mmhg as measured by continuous invasive arterial blood pressure monitoring. Invasive arterial blood pressure monitoring is a commonly used intraoperative monitor involving a 20 guage polyvinylchloride arterial cannula placed in a peripheral artery with direct manometry via a commercially prepared strain guage transducer, and it's placement is required for Flotrac CI monitoring.
Timepoint [5] 367569 0
intraoperative time
Secondary outcome [6] 367570 0
Duration of MAP <20% of baseline as measured by continuous invasive arterial blood pressure monitoring. Invasive arterial blood pressure monitoring is a commonly used intraoperative monitor involving a 20 guage polyvinylchloride arterial cannula placed in a peripheral artery with direct manometry via a commercially prepared strain guage transducer, and it's placement is required for Flotrac CI monitoring.
Timepoint [6] 367570 0
intraoperative time
Secondary outcome [7] 367571 0
in-hospital mortality as defined by hospital records
Timepoint [7] 367571 0
duration of inpatient postoperative stay
Secondary outcome [8] 367572 0
postoperative cognitive impairment as measured by AMT
Timepoint [8] 367572 0
postoperative days 1-5
Secondary outcome [9] 367573 0
acute kidney injury as measured by RIFLE criteria
Timepoint [9] 367573 0
duration of inpatient stay
Secondary outcome [10] 367574 0
MACE as defined by EPCO definitions
Timepoint [10] 367574 0
postoperative inpatient stay

Eligibility
Key inclusion criteria
All patients who have received Fractured NOFF surgery and have provided consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2019
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
47
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13241 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 25799 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 302070 0
Hospital
Name [1] 302070 0
Austin Hospital Operating Suite
Country [1] 302070 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Masimo
Address
Masimo Australia
Ste 3/ 49 Frenchs Forest Road, Frenchs Forest NSW 2086
Country
Australia
Secondary sponsor category [1] 301886 0
None
Name [1] 301886 0
Address [1] 301886 0
Country [1] 301886 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302752 0
Austin Health HREC
Ethics committee address [1] 302752 0
Ethics committee country [1] 302752 0
Australia
Date submitted for ethics approval [1] 302752 0
25/03/2019
Approval date [1] 302752 0
Ethics approval number [1] 302752 0

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

Contacts
Principal investigator
Name 91274 0
Dr Chong Tan
Address 91274 0
Austin hospital 145 Studley Rd Heidelberg VIC 3084
Country 91274 0
Australia
Phone 91274 0
+61 3 9496 5704
Fax 91274 0
Email 91274 0
[email protected]
Contact person for public queries
Name 91275 0
Chong Tan
Address 91275 0
Austin hospital 145 Studley Rd Heidelberg VIC 3084
Country 91275 0
Australia
Phone 91275 0
+61 3 9496 5704
Fax 91275 0
Email 91275 0
[email protected]
Contact person for scientific queries
Name 91276 0
Chong Tan
Address 91276 0
Austin hospital 145 Studley Rd Heidelberg VIC 3084
Country 91276 0
Australia
Phone 91276 0
+61 3 9496 5704
Fax 91276 0
Email 91276 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• -

What individual participant data might be shared?
• All non-/ re-identifiable data that is permitted by our health care networks liability policy

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
From study closure and final analysis onwards, to 5 years thereafter

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• access subject to approvals by Principal Investigator

Are there extra considerations when requesting access to individual participant data?
No


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
No additional documents have been identified.