Trial Review

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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
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)
Secondary ID [1] 283369 0
'Nil'
Universal Trial Number (UTN)
U1111-1143-6310
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients in High Acuity Areas 290002 0
Condition category
Condition code
Respiratory 290386 290386 0 0
Other respiratory disorders / diseases
Public Health 290657 290657 0 0
Health service research

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 287876 0
Treatment: Devices
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.
Control group
Historical

Outcomes
Primary outcome [1] 290408 0
Requirement for escalation of care – Invasive ventialtion or Noninvasive ventilation within 24 hours
Timepoint [1] 290408 0
24 Hours
Primary outcome [2] 290671 0
ICU/HDU/CCU Length of stay in hours
Timepoint [2] 290671 0
At ICU/HDU/CCU Discharge
Primary outcome [3] 290672 0
In-hospital mortality and or morbidity during this hospital admission as recorded in medical notes by clinical assessment by attending specialist
Timepoint [3] 290672 0
During this hospital admission
Secondary outcome [1] 304439 0
Cost benefit Analysis
Timepoint [1] 304439 0
1 Year

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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion will only occur if there is a known contraindication to Optiflow (e.g. as per device specification)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Historical control
Phase
Not Applicable
Type of endpoint/s
Efficacy
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)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2013
Actual
20/05/2013
Date of last participant enrolment
Anticipated
25/12/2014
Actual
1/03/2014
Date of last data collection
Anticipated
Actual
15/06/2016
Sample size
Target
500
Accrual to date
Final
500
Recruitment outside Australia
Country [1] 5386 0
New Zealand
State/province [1] 5386 0

Funding & Sponsors
Funding source category [1] 287898 0
Commercial sector/Industry
Name [1] 287898 0
Fisher & Paykel Healthcare NZ
Country [1] 287898 0
New Zealand
Primary sponsor type
Hospital
Name
Tauranga Hospital, Bayof Plenty District Health Board
Address
Cameron Road, Tauranga, New Zealand, 3110
Country
New Zealand
Secondary sponsor category [1] 286625 0
None
Name [1] 286625 0
Address [1] 286625 0
Country [1] 286625 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289837 0
Bay of Plenty District Health Board Research Unit
Ethics committee address [1] 289837 0
Ethics committee country [1] 289837 0
New Zealand
Date submitted for ethics approval [1] 289837 0
17/04/2013
Approval date [1] 289837 0
18/04/2013
Ethics approval number [1] 289837 0
Ethics committee name [2] 289838 0
Health and Disablity Ethics Committee
Ethics committee address [2] 289838 0
Health and Disability Ethics Committees
1 the Terrace
PO Box 5013
Wellington 6145
Ethics committee country [2] 289838 0
New Zealand
Date submitted for ethics approval [2] 289838 0
17/04/2013
Approval date [2] 289838 0
18/04/2013
Ethics approval number [2] 289838 0

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.
Trial website
Trial related presentations / publications
Critical Care October 2015, Vol 148, No. 4_MeetingAbstracts
Public notes
Attachments [1] 2900 2900 0 0
/AnzctrAttachments/364331-1-s2.0-S0012369216362298-main.pdf (Publication)

Contacts
Principal investigator
Name 40382 0
Dr Troy Browne
Address 40382 0
Director of ICU/HDU
Tauranga Hospital
Cameron Road
Tauranga
New Zealand 3112
Country 40382 0
New Zealand
Phone 40382 0
+64 7 5798710
Fax 40382 0
Email 40382 0
troy.browne@bopdhb.govt.nz
Contact person for public queries
Name 40383 0
Ms Jennifer Goodson
Address 40383 0
Tauranga Hospital
Cameron Road
Tauranga
New Zealand 3112
Country 40383 0
New Zealand
Phone 40383 0
+64 7 5798710
Fax 40383 0
Email 40383 0
jennifer.goodson@bopdhb.govt.nz
Contact person for scientific queries
Name 40384 0
Dr Troy Browne
Address 40384 0
Director of ICU/HDU
Tauranga Hospital
Cameron Road
Tauranga
New Zealand 3112
Country 40384 0
New Zealand
Phone 40384 0
+ 64 7 5798710
Fax 40384 0
Email 40384 0
troy.browne@bopdhb.govt.nz

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.