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Trial registered on ANZCTR


Registration number
ACTRN12613001264774
Ethics application status
Approved
Date submitted
13/11/2013
Date registered
18/11/2013
Date last updated
23/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
High Flow Humidified Nasal Cannula versus Standardised Oxygen Therapy
Scientific title
A comparative study of high flow humidified nasal cannula versus standardised oxygen therapy for adult patients who present to the emergency department in respiratory distress. Success will be determined by a decrease in respiratory rate by 20% by the end of the second hour from the time therapy was commenced.
Secondary ID [1] 283539 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory 290449 0
Dyspnoea 290489 0
Condition category
Condition code
Respiratory 290841 290841 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Humidified high flow nasal cannula is a supplementary oxygen therapy that provides a complete range of flow as well as fraction of inspired oxygen (Fi02) beyond that of standard oxygen therapy.

The higher flows up to 60 litres allows the patients inspiratory demand to be met. With the aim to reduce their work of breathing. Additionally being able to prescribe the Fi02 (ranges between 21%-100%) independently to the flow to meet the patients individual needs.

Adult patients who present to one of two metropolitan Emergency Departments with dyspnoea and a respiratory rate greater or equal to 25 and oxygen saturations of equal or less than 93% on room air will be randomised to either high flow nasal cannula or standard oxygen therapy.

Both therapies will be titrated to the patients individual requirements while in the Emergency Department (ED). We will be assessing the outcomes of the treatment for the duration of the patient stay in the ED
Intervention code [1] 288251 0
Treatment: Devices
Comparator / control treatment
If the patient meets the inclusion criteria they could be randomised to either high flow nasal cannula or standard oxygen therapy. Standard oxygen therapy equates to nasal prong oxygen, venturi mask, face mask or non-rebreather mask depending on the patients needs. We will be assessing the outcomes of the treatment for the duration of the patient stay in the ED
Control group
Active

Outcomes
Primary outcome [1] 290851 0
Success will be determined by a decrease in the patient’s respiratory rate by 20% without requiring escalation to either humidified high flow, non invasive ventilation or invasive ventilation. The need for escalation will be at the discretion of the treating clinician.

The primary outcome between the two groups will be compared using Chi Square tests.
Timepoint [1] 290851 0
At the end of the second hour from the time therapy is commenced
Secondary outcome [1] 305492 0
The patient's disposition time will be captured. This is routinely done using the ED data base by medical, nursing and clerical.
Continous outcomes will be compared using Wilcoxon rank sum test.
Timepoint [1] 305492 0
Time collected on the ED database
Secondary outcome [2] 305493 0
Delay to ward transfer (yes/no) will be collected on the ED database. The data will be analysed using Chi square tests.
Timepoint [2] 305493 0
The length of stay and if there was a delay will be collected at the time patient departs from the ED.
Secondary outcome [3] 305494 0
Length of stay in the hospital (days) will be defined as day of arrival to discharge. The continous outcome will be compared using Wilcoxon rank sum test.
Timepoint [3] 305494 0
Day of discharge from an inpatient department
Secondary outcome [4] 305495 0
Unexpected adverse events (death, ICU admission, NIV, intubation,) will be recorded in the clinical notes and on the data collection form. All analysis will be intention-to-treat. Each event will be compared using Chi square test
Timepoint [4] 305495 0
During the patient's length of stay in the ED that will be capture in hours and minutes from arrival to the ED to admission to an inpatient ward/unit.
Secondary outcome [5] 305496 0
Patient comfort during the administration of the oxygen therapy will be measured using a 5 point Likert scale and self rated dyspnoea (Borg) scale. Data will be analysied comparing the two groups using Chi Sqaure tests.
Timepoint [5] 305496 0
This will be assessed periodically in the first 2 hours from when the therapy was commenced.

Eligibility
Key inclusion criteria
Patients who are 16years and over who present with dyspnoea and a respiratory rate great or equal to 25 and oxygen saturations of less than or equal to 93% on room air to either Royal Prince Alfred ED or Canterbury Hospital ED
Minimum age
16 Years
Maximum age
110 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients presenting to the ED who require immediate BiPAP or intubation/ventilation
2. Any patient under the age 16
3. Patients who have received a trauma call; including facial trauma, chest trauma
4. Patients with suspected spontaneous pneumothorax
5. Patients who are unable to provide informed consent (cognitive impairment, intoxication from drugs and/or alcohol, intellectual disability, mental illness)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting to either Royal Prince Alfred (RPA) or Canterbury Hospital (CH) acutely short of breath and a RR greather or equal to 25 or saturation less than or equal to 93% will be offered the oportunity to participate in the study.

They patient will be enrolled and consented by a staff member independent to the treating team.

Randomisation of High Flow Humidifed Nasal Cannula (HFHNC) or standard oxygen therapy will be achieved by computer generated allocation. The allocated therapy will be kept in numbered individual sealed opaque envelopes and will be only opened and revealed to staff and patient once the patient has been consented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was done using a sequencing program in Microsoft Excel 2007
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/11/2013
Actual
25/11/2013
Date of last participant enrolment
Anticipated
Actual
14/02/2015
Date of last data collection
Anticipated
Actual
14/02/2015
Sample size
Target
100
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1680 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 1681 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 7554 0
2050 - Missenden Road
Recruitment postcode(s) [2] 7555 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 288259 0
Hospital
Name [1] 288259 0
Royal Prince Alfred Hospital
Country [1] 288259 0
Australia
Funding source category [2] 288260 0
Hospital
Name [2] 288260 0
Canterbury Hospital
Country [2] 288260 0
Australia
Primary sponsor type
Individual
Name
Nerida Bell
Address
Royal Prince Alfred
Emergency Department
Missenden Rd
Camperdown
NSW
2050
Country
Australia
Secondary sponsor category [1] 286977 0
Individual
Name [1] 286977 0
Claire Hutchinson
Address [1] 286977 0
Canterbury Hospital
Emergency Department
Canterbury Road
Campsie
NSW
2194
Country [1] 286977 0
Australia
Other collaborator category [1] 277690 0
Individual
Name [1] 277690 0
Assoc Prof Michael Dinh
Address [1] 277690 0
Royal Prince Alfred
Emergency Department
Missenden Rd
Camperdown
NSW
2050
Country [1] 277690 0
Australia
Other collaborator category [2] 277691 0
Individual
Name [2] 277691 0
Dr Kendall Bein
Address [2] 277691 0
Royal Prince Alfred Hospital
Emergency Department
Missenden Road
Camperdown
NSW
2050
Country [2] 277691 0
Australia
Other collaborator category [3] 277692 0
Individual
Name [3] 277692 0
Dr Simon Rodda
Address [3] 277692 0
Canterbury Hospital
Emergency Department
Canterbury Road
Campsie
NSW
2194
Country [3] 277692 0
Australia
Other collaborator category [4] 277693 0
Individual
Name [4] 277693 0
Dr Eileen Rogan
Address [4] 277693 0
Canterbury Hospital
Emergency Department
Canterbury Road
Campsie
NSW
2194
Country [4] 277693 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290161 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 290161 0
Ethics committee country [1] 290161 0
Australia
Date submitted for ethics approval [1] 290161 0
07/08/2013
Approval date [1] 290161 0
01/11/2013
Ethics approval number [1] 290161 0
HREC/13/RPAH/367

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2906 2906 0 0
/AnzctrAttachments/365269-High Flow Article.pdf (Publication)

Contacts
Principal investigator
Name 44134 0
Ms Nerida Bell
Address 44134 0
Royal Prince Alfred Hospital
Emergency Department
Missenden rd
Camperdown
NSW 2050
Country 44134 0
Australia
Phone 44134 0
+61 2 95158912
Fax 44134 0
Email 44134 0
Nerida.Bell1@health.nsw.gov.au
Contact person for public queries
Name 44135 0
Nerida Bell
Address 44135 0
Royal Prince Alfred Hospital
Emergency Department
Missenden rd
Camperdown
NSW 2050
Country 44135 0
Australia
Phone 44135 0
+61 2 95158912
Fax 44135 0
Email 44135 0
Nerida.Bell1@health.nsw.gov.au
Contact person for scientific queries
Name 44136 0
Nerida Bell
Address 44136 0
Royal Prince Alfred Hospital
Emergency Department
Missenden rd
Camperdown
NSW 2050
Country 44136 0
Australia
Phone 44136 0
+61 2 95158912
Fax 44136 0
Email 44136 0
Nerida.Bell1@health.nsw.gov.au

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.