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Trial registered on ANZCTR
Registration number
ACTRN12614000458639
Ethics application status
Approved
Date submitted
5/09/2013
Date registered
2/05/2014
Date last updated
20/07/2018
Type of registration
Retrospectively registered
Titles & IDs
Public title
Evaluation of the use of Optiflow (Trade Mark) as a standard of care for oxygen delivery in critically ill patients in high acuity areas
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Scientific title
To demonstrate what Optiflow (Trademark) as a standard of care for oxygen delivery has on clinical outcomes in high acuity patients in a combined unit (ICU/CCU/HDU)
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Secondary ID [1]
283369
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'Nil'
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Universal Trial Number (UTN)
U1111-1143-6310
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Patients in High Acuity Areas
290002
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Condition category
Condition code
Respiratory
290386
290386
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0
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Other respiratory disorders / diseases
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Public Health
290657
290657
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
To demonstrate that when Optiflow is introduced as the standard of care for oxygen delivery in a combined unit (ICU/CCU/HDU) superior outcomes shall be achieved.
Optiflow delivers a wide range of oxygen percentages and flows. Optiflow is a medical device. Optiflow is a nasal cannula device and will be utilised for the duration of the patient's ICU/CCU/HDU stay
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Intervention code [1]
287876
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Treatment: Devices
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Comparator / control treatment
One site only Tauranga Hospital New Zealand
Optiflow vs Standard Care - The default for standard care will be the use of optiflow for the delivery of oxygen.
Historical Standard of care was oxygen delivered via nasal cannulae or face mask.
Historical data collected from patients notes, admitted to the ICU/HDU/CCU from 20 May to 20 November 2012.
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Control group
Historical
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Outcomes
Primary outcome [1]
290408
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Requirement for escalation of care – Invasive ventialtion or Noninvasive ventilation within 24 hours
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Assessment method [1]
290408
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Timepoint [1]
290408
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24 Hours
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Primary outcome [2]
290671
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ICU/HDU/CCU Length of stay in hours
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Assessment method [2]
290671
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Timepoint [2]
290671
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At ICU/HDU/CCU Discharge
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Primary outcome [3]
290672
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In-hospital mortality and or morbidity during this hospital admission as recorded in medical notes by clinical assessment by attending specialist
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Assessment method [3]
290672
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Timepoint [3]
290672
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During this hospital admission
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Secondary outcome [1]
304439
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Cost benefit Analysis
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Assessment method [1]
304439
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Timepoint [1]
304439
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1 Year
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Eligibility
Key inclusion criteria
All patients admitted to the ICU/HDU/CCU will be eligible for enrolment (convenience sampling) and there will be no withdrawals.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion will only occur if there is a known contraindication to Optiflow (e.g. as per device specification)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Historical control
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
1. Descriptive data: Means or medians with Standard Deviation
2. Ordinal data: N or %, with comparisons of ordinal data by X2
3. Continuous data: Mann-Whitney test
4. Sample size was based on historical control Convenience sample)
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
20/05/2013
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Actual
20/05/2013
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Date of last participant enrolment
Anticipated
25/12/2014
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Actual
1/03/2014
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Date of last data collection
Anticipated
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Actual
15/06/2016
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Sample size
Target
500
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Accrual to date
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Final
500
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Recruitment outside Australia
Country [1]
5386
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New Zealand
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State/province [1]
5386
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Funding & Sponsors
Funding source category [1]
287898
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Commercial sector/Industry
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Name [1]
287898
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Fisher & Paykel Healthcare NZ
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Address [1]
287898
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15 Maurice Paykel Place
East Tamaki
Auckland 2013
New Zealand
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Country [1]
287898
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New Zealand
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Primary sponsor type
Hospital
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Name
Tauranga Hospital, Bayof Plenty District Health Board
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Address
Cameron Road, Tauranga, New Zealand, 3110
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Country
New Zealand
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Secondary sponsor category [1]
286625
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None
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Name [1]
286625
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Address [1]
286625
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Country [1]
286625
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289837
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Bay of Plenty District Health Board Research Unit
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Ethics committee address [1]
289837
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Ethics committee country [1]
289837
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New Zealand
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Date submitted for ethics approval [1]
289837
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17/04/2013
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Approval date [1]
289837
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18/04/2013
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Ethics approval number [1]
289837
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Ethics committee name [2]
289838
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Health and Disablity Ethics Committee
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Ethics committee address [2]
289838
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Health and Disability Ethics Committees
1 the Terrace
PO Box 5013
Wellington 6145
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Ethics committee country [2]
289838
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New Zealand
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Date submitted for ethics approval [2]
289838
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17/04/2013
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Approval date [2]
289838
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18/04/2013
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Ethics approval number [2]
289838
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Summary
Brief summary
The efficacy of introducing Optiflow as standard of care needs to be established in a robust way. It is proposed that a clinical reference centre will be established at the ICU/HDU/CCU at Tauranga Hospital (BOP DHB) where Optiflow will be introduced as the standard of care, therefore replacing all other oxygen delivery devices in use within the ICU, excluding NIV and INV devices. Tauranga Hospital is a secondary hospital that provides medical, surgical, paediatric, obstetric, gynaecology and mental health services to the population of the Western Bay of Plenty.
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Trial website
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Trial related presentations / publications
Critical Care October 2015, Vol 148, No. 4_MeetingAbstracts
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Public notes
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Attachments [1]
2900
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/AnzctrAttachments/364331-1-s2.0-S0012369216362298-main.pdf
(Publication)
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Contacts
Principal investigator
Name
40382
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Dr Troy Browne
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Address
40382
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Director of ICU/HDU
Tauranga Hospital
Cameron Road
Tauranga
New Zealand 3112
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Country
40382
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New Zealand
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Phone
40382
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+64 7 5798710
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Fax
40382
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Email
40382
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[email protected]
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Contact person for public queries
Name
40383
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Ms Jennifer Goodson
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Address
40383
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Tauranga Hospital
Cameron Road
Tauranga
New Zealand 3112
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Country
40383
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New Zealand
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Phone
40383
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+64 7 5798710
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Fax
40383
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Email
40383
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[email protected]
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Contact person for scientific queries
Name
40384
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Dr Troy Browne
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Address
40384
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Director of ICU/HDU
Tauranga Hospital
Cameron Road
Tauranga
New Zealand 3112
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Country
40384
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New Zealand
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Phone
40384
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+ 64 7 5798710
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Fax
40384
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Email
40384
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[email protected]
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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
No additional documents have been identified.
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