Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000587404
Ethics application status
Approved
Date submitted
15/03/2016
Date registered
6/05/2016
Date last updated
6/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Breathe Easy Early Study (BEES): A randomised control study assessing the efficacy of early intervention with humidified high flow nasal cannula in the emergency department-Optimising outcomes in the Golden Hour of Respiratory failure.
Scientific title
The Breathe Easy Early Study: A randomised control study assessing the efficacy of early intervention with humidified high flow nasal cannula in the emergency department-Optimising outcomes in the Golden Hour of Respiratory failure.
Secondary ID [1] 288708 0
NONE
Universal Trial Number (UTN)
nil known
Trial acronym
BEES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory illnesses 297936 0
Chronic respiratory conditions 297937 0
Congestive Heart Failure 297939 0
Acute Respiratory illnesses 297940 0
Condition category
Condition code
Cardiovascular 298099 298099 0 0
Other cardiovascular diseases
Respiratory 298101 298101 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Humidified High Flow Nasal Cannula (HHFNC) is a therapy that utilises heated humidified blend of gases (i.e. Oxygen, Room Air) via large bore nasal cannula. Due to humidification, high flow therapy can deliver flows of up to 60lt min and titrated fraction of inspired oxygen (Fi02).
In this study, patients randomised to HHFNC will be commenced on 60lt/min and Fio2 titrated as per protocol. Oxygen concentration will depend on patients individual room air staurations after 10mins on 60lt. If patients Sp02 <94% (for non- COPD patients),then the FiO2 is tritated to achieve O2 saturations of >94%. If patients Spo2 < 88% (for known COPD patients), then Fio2 is tritated to achieve between 88%-92% O2 saturations. The duration of HHFNC therapy will depend on the individual patients clinical observations.
Weaning off HHFNC therapy will occur when respiratory rate is <20bpm,SpO2 is within target ranges specified above in <50% FiO2 and improvement in the dyspnoea scale. Purpose made observation charts are utilised to monitor adherence and aid in data collection.
Intervention code [1] 294139 0
Treatment: Devices
Intervention code [2] 294652 0
Treatment: Other
Comparator / control treatment
Once patients are assessed and flagged as a potential participant in this study, they will be randomised to either standard therapy (control) or HHFNC therapy (intervention). If they are randomised to the control group then they will be placed on nasal prongs, hudson mask or non-rebreather mask as per standard therapy to patients who present with respiratory distress. Standard therapy used is dry oxygen from a flow metre attached to the wall of cubicles. The O2 concentration, flow rate and type of delivery (i.e. nasal prongs or mask) are dependent on the clinical severity of the patient and response. If there is no improvement or worsening symptoms then the patients can be escalated to the HHFNC arm or other (i.e. Bi-Pap) at the discretion of the physician.
Control group
Active

Outcomes
Primary outcome [1] 297614 0
The primary outcome will be the proportion of patients who experience relief of dyspnea. This will be defined as a reduction of 20 points on a 100mm visual analogue scale (VAS), reduction in heart and respiratory rate prior to discharge from ED. The proportion of patients who achieve dyspnea relief in each group will be reported and the differences between each group (with a 95% confidence interval of the difference) will be reported.
Timepoint [1] 297614 0
Baseline visual analogue scale( VAS) - Included as part of the initial assessment (prior to any or just as initial intervention takes place), then will continue 30minutely for 90minutes whilst in the ED. If patient is admitted to the ward then hourly-4hrly depending on the patients clinical condition or wards protocol.
Secondary outcome [1] 321585 0
Time to relief of dyspnea. Defined as the amount of time it takes for the patient to report decreased dyspnea and also objective observations such as decreased respiratory rate, work of breathing, and heart rate.
Timepoint [1] 321585 0
The time to relief of dyspnea will be recorded by nursing staff on a purpose made observation chart from first assessment.These will occur every 30 minutes initially for 90 minutes/if very unwell, 15minutely intervals whilst in ED.
If patient is admitted to the ward then hourly -4hrly depending on the patients clinical condition or wards protocol.
Secondary outcome [2] 321586 0
Time requiring respiratory supplementation. Defined as the length of time it takes until therapy has concluded, either in the ED or the hospital ward. This outcome will be assessed using direct observation and use of a purpose made abservation chart.
Timepoint [2] 321586 0
Measured from when first observations recorded until removed from therapy.
Secondary outcome [3] 321647 0
Length of stay (LOS) in the Emergency Department. will be assessed by review of the Emeregency Department Information System (EDIS).
Timepoint [3] 321647 0
Defined as arrival time at triage to discharge from the ED. This is from time of arrival recorded on EDIS and actual departure from ED recorded on EDIS.This time will be used for analysis purposes.
Secondary outcome [4] 321648 0
Overall length of stay (LOS).Defined as from patients initial triage contact to discharge from ward/hospital.
Timepoint [4] 321648 0
This outcome is assessed following patients discharge from the ward, either by review of clinicians notes in their medical chart or an electronic discharge system called 'the viewer'.

Eligibility
Key inclusion criteria
18 years and over
Symptomatic breathlessness- increased respiratory rate > 25 breaths per min and observed increased work of breathing.
Patients requiring oxygen supplementation to maintain Sp02 > 94% for acutely unwell patient OR 88% to 92% for those at risk of hypercapnic respiratory failure (in line with recruiting site hospital).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent ENT surgery
Epistaxis/ nasal trauma/ sinus problems
Altered level of consciousness
Pregnancy
Non invasive ventilation at point of triage
Pneumothorax/chest trauma
History of trauma eg. post fall
Falling GCS or GCS <9

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)
Sealed opaque envelopes generated by computer software
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
For patients who are too unwell to give written consent informed consent at the time of enrollment, delayed consent will be used.(approval for delayed consent has been approved by an Ethics and Governence commitee)
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2016
Actual
Date of last participant enrolment
Anticipated
30/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
268
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 12906 0
4305 - Ipswich

Funding & Sponsors
Funding source category [1] 293081 0
Other
Name [1] 293081 0
Queensland Medical Emergency Research Fund
Country [1] 293081 0
Australia
Funding source category [2] 293082 0
Hospital
Name [2] 293082 0
Ipswich Hospital Research and Innovation Fund
Country [2] 293082 0
Australia
Primary sponsor type
Hospital
Name
Ipswich Hospital
Address
Chelmsford Avenue
Ipswich, QLD, 4305
Country
Australia
Secondary sponsor category [1] 291913 0
None
Name [1] 291913 0
N/A
Address [1] 291913 0
N/A
Country [1] 291913 0
Other collaborator category [1] 278885 0
Charities/Societies/Foundations
Name [1] 278885 0
Critical Care Research Group
Address [1] 278885 0
Prince Charles Hospital
Rode Road, Chermside Queensland 4032
Country [1] 278885 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294577 0
The Prince Charles Hospital Research Ethics Committee
Ethics committee address [1] 294577 0
The Prince Charles Hospital Building 14
Rode Rd, Chermeside
QLD, 4032
Ethics committee country [1] 294577 0
Australia
Date submitted for ethics approval [1] 294577 0
Approval date [1] 294577 0
11/12/2015
Ethics approval number [1] 294577 0
HREC/15/QPCH/180

Summary
Brief summary
Tne Breathe Easy Early study is a randomised control trial to assess the efficacy of early intervention with humidified high flow nasal cannula in the emergency department- Optimising outcomes in the Golden Hour of respiaratory failure.
Many patients present to the emergency department frequently feeling breathless. The cause of the breathlessness is varied and can be caused by problems with the heart, lungs, cancer or infection. On presentation to the emergency department, standard treatment of the breathless patient involves the application of oxygen via a face mask in addition to drug therapy and investigations including chest xrays and blood tests. If
breathlessness gets worse, the patient may need breathing support in the way of non invasive or invasive breathing support which requires intensive nursing and medical care. Despite the benefit of these therapies they come with inherent risks to the patient. A breathing support device that provides noninvasive humidified high flow via a nasal cannula is one method of breathing support that is currently utilised safely in the critical care units of adult and paediatric hospitals. The high flow delivery provides small amounts of pressure to reduce the effort exerted by the patient while breathing in and to help splint the airways open. This pressure is not present during simple oxygen therapy. Additionally, the humidification of the high flow therapy helps maintain normal airway and lung function, by not drying out the airways. If we treat patients early with high flow therapy rather than using the standard facemask, we may be able to relieve symptoms of shortness of breath sooner and avoiding the worsening of breathing difficulties.

Research Design and Methods:
Ipswich Hospital Emergency Department will be the pilot site for this randomised controlled trial of early intervention with humidified high flow nasal cannula (HHFNC) vs. standard practice in the breathless patient. Patients that present to the Ipswich Hospital ED with dyspnoea will be identified at the point of triage and flagged as potential participants in the study. Participants will be randomised to receive study arm (HHFNC) or standard practice.

Outcomes:
The Primary outcome will be the proportion of patients who experience relief of dyspnoea.
The secondary outcomes will include
Time to relief of dyspnoea
Time requiring respiratory supplementation
Health care cost reduction with early initiation of supportive respiratory support
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64218 0
Dr Kylie Baker
Address 64218 0
Ipswich General Hospital, Emergency Department
Chelmsford Avenue, Ipswich, QLD
4305
Country 64218 0
Australia
Phone 64218 0
+61 412 478 036
Fax 64218 0
Email 64218 0
[email protected]
Contact person for public queries
Name 64219 0
Ms Tanya Greaves
Address 64219 0
Ipswich General Hospital, Emergency Department
Chelmsford Avenue, Ipswich, QLD
4305
Country 64219 0
Australia
Phone 64219 0
+61 411747090
Fax 64219 0
Email 64219 0
[email protected]
Contact person for scientific queries
Name 64220 0
Dr Kylie Baker
Address 64220 0
Ipswich General Hospital, Emergency Department
Chelmsford Avenue, Ipswich, QLD
4305
Country 64220 0
Australia
Phone 64220 0
+61 412 478 036
Fax 64220 0
Email 64220 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
No additional documents have been identified.