Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000209392
Ethics application status
Approved
Date submitted
2/02/2017
Date registered
8/02/2017
Date last updated
30/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial to evaluate feasibility and benefits of adding Nasal High Flow in a hospital in the home setting following acute hospital presentations for exacerbation of chronic obstructive pulmonary disease.
Scientific title
Feasibility trial to evaluate benefits of commencing Nasal High Flow following acute inpatient exacerbations of chronic obstructive pulmonary disease.
Secondary ID [1] 290998 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 301768 0
Condition category
Condition code
Respiratory 301457 301457 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Consented patients with COPD exacerbations presenting to two tertiary level sites across a hospital network (Monash Medical Centre and Dandenong hospital) with be recruited within 24 hours of admission/medical stability and enrolled into the trial. . After a brief opportunity to trial Nasal High Flow (NHF), patients will be consented to ongoing periodic use of the NHF (AIRVO Fisher Paykel) with the expectation of discharge to the Hospital in the Home (HITH) program within 24 hours of consenting. NHF is a device that delivers high flow rates of humidified air or O2 up to a maximum of 60L/Min. NHF flushes the upper airway reducing effective anatomical deadspace, provides low levels of positive end expiratory pressure and humidifies the airway to improve mucociliary clearance. It is hypothesised this treatment will assist in early discharge and ongoing usage in the home setting will reduce readmission.
NHF will be administered at 30L/min set at 37 degrees. The device does not deliver a preset pressure which will vary according to the patient up to 2-3cmH20. Supplemental O2 may be co-administered determined by the clinical care team.

Care will continue at home for the remainder of their acute illness including daily periodic use of NHF for 30 days in the HITH setting. Compliance will be encouraged by daily visits for the first week and twice weekly thereafter by qualified nursing staff familiar with NHF. Compliance will be recorded from device monitor. Patients will receive bronchodilators, oral corticosteroids, antibiotics and where indicated supplemental O2 as part of their routine care prescribed by their inpatient care team. In addition patients will be maintained on NHF as much as is tolerable with minimum usage of 6 hours per day for 30 days. Patients will be encouraged to use the device overnight to achieve target usage.

As this is a feasibility trial outcomes will be compared to matched historic controls.
Intervention code [1] 296958 0
Treatment: Devices
Comparator / control treatment
A similar number of de-identified matched historic controls recorded over the twelve months prior to study commencement will be collected. These patients will have presented to the emergency departments of Monash Medical Centre and Dandenong hospital and admitted receiving standard care for COPD exacerbations. This will have included bronchodilators, oral and/or inhaled steroids, antibiotics and where indicated supplemental O2. Data will be collected from the Monash health medical record data base from coded COPD admissions. Matched consecutive patients will be de-identified and outcome variables will be collected including hospital length of stay and 30 and 60 day readmission rate
Control group
Historical

Outcomes
Primary outcome [1] 300854 0
Inpatient Length of inpatient (LOS) stay (compared to historic matched controls) as determined from the hospital medical record
Timepoint [1] 300854 0
30 and 60 day re-admission from time of discharge from the acute facility (compared to historic matched controls). Readmission may include return to the acute facility whilst in the HITH program.
Primary outcome [2] 300935 0
Length of acute hospital stay as determined from the medical record
Timepoint [2] 300935 0
acute hospital stay
Secondary outcome [1] 331040 0
Treatment effectiveness (Uptake into the HITH program as a percentage of COPD presentations)
Timepoint [1] 331040 0
60 days from the discharge from the acute facility.
Secondary outcome [2] 331242 0
Post hoc comparision of prospectively monitored 30 and 60 day readmissions with NHF compliance determined from the device meter
Timepoint [2] 331242 0
30 and 60 days

Eligibility
Key inclusion criteria
- Chronic obstructive pulmonary disease (COPD) GOLD classification 2-4

- COPD exacerbation as the principle reason to attend the emergency department
Minimum age
35 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Unable to provide informed consent

- Significant asthma contributing to presentation

- Ongoing severe respiratory distress at 24 hours of hospitalisation with one or more of:
- Bed/chair bound due to dyspnoea
- Respiratory rate > 30
- PaCO2 >50mmHg
- Arterial pH <7.35
- Systolic BP <90mmHg
- Altered conscious state/delirium
- Medical co-morbidity precluding discharge
- Requirement for intravenous therapy
- Outside HITH catchment

- Homelessness

- No telephone contact

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
120 subjects recruited at a rate of 4 per week across two hospital sites will be enrolled. This is powered to detect a halving of inpatient length of stay from the current 6 days and a 25% reduction in 60 day readmission rate from the current 25% of patients. Recruitment is expected to continue for 30 weeks.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2017
Actual
1/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7382 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [2] 7383 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 15175 0
3168 - Clayton
Recruitment postcode(s) [2] 15176 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 295422 0
Commercial sector/Industry
Name [1] 295422 0
Fisher Paykel
Country [1] 295422 0
Australia
Primary sponsor type
Individual
Name
AProf Darren Mansfield
Address
Monash Lung and Sleep
Monash Health 246 Clayton Rd Clayton Victoria 3168
Country
Australia
Secondary sponsor category [1] 294242 0
None
Name [1] 294242 0
Address [1] 294242 0
Country [1] 294242 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296753 0
Monash Health Human Research Ethics Committee
Ethics committee address [1] 296753 0
Level 2, I Block Monash Medical Centre 246 Clayton Rd Clayton Victoria 3168
Ethics committee country [1] 296753 0
Australia
Date submitted for ethics approval [1] 296753 0
15/02/2017
Approval date [1] 296753 0
19/04/2017
Ethics approval number [1] 296753 0
HREC/17/MonH/70

Summary
Brief summary
Prospective feasibility trial with historic controls to explore the implementation and effectiveness of NHF in hospitalised COPD patients to facilitate discharge and 30 days of ongoing usage following discharge in the HITH setting to reduce 30 and 60 day readmission rate.
Trial website
N/A
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71962 0
A/Prof Darren Mansfield
Address 71962 0
Monash Lung and Sleep Monash Health 246 Clayton Rd Clayton 3168 Victoria
Country 71962 0
Australia
Phone 71962 0
+613 9594 6666
Fax 71962 0
+61395946415
Email 71962 0
[email protected]
Contact person for public queries
Name 71963 0
Darren Mansfield
Address 71963 0
Monash Lung and Sleep Monash Health 246 Clayton Rd Clayton 3168 Victoria
Country 71963 0
Australia
Phone 71963 0
+613 9594 6666
Fax 71963 0
+61395946415
Email 71963 0
[email protected]
Contact person for scientific queries
Name 71964 0
Darren Mansfield
Address 71964 0
Monash Lung and Sleep Monash Health 246 Clayton Rd Clayton 3168 Victoria
Country 71964 0
Australia
Phone 71964 0
+613 9594 6666
Fax 71964 0
+61395946415
Email 71964 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

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