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Trial registered on ANZCTR


Registration number
ACTRN12617001278325
Ethics application status
Approved
Date submitted
31/08/2017
Date registered
6/09/2017
Date last updated
22/02/2019
Date data sharing statement initially provided
22/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study designed to test a new oxygen delivery device (NHFO2) in patients with long term respiratory disease who require home oxygen.
Scientific title
A study designed to test the ability of a novel oxygen delivery system (NHFO2) to autotitrate the delivered inspired oxygen concentration (FiO2) to a target arterial oxygen saturation (SpO2) in participants with chronic respiratory disease on long term oxygen therapy (LTOT).
Secondary ID [1] 292784 0
None
Universal Trial Number (UTN)
U1111-1201-0146
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 304588 0
Interstitial lung disease 304589 0
Bronchiectasis 304590 0
Any other doctor diagnosed chronic respiratory condition with requirement for long term oxygen therapy (LTOT) 304591 0
Condition category
Condition code
Respiratory 303918 303918 0 0
Chronic obstructive pulmonary disease
Respiratory 303919 303919 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study assesses the performance of a novel oxygen delivery device called a nasal high flow oxygen titration device (NHFO2). This is a newly developed device which delivers heated, humidified high flow oxygen via nasal cannulae at an FiO2 which is automatically titrated to a set patient target SpO2.

The device will be applied by a medically qualified trial doctor or allocated trained technician to patients with chronic respiratory disease on LTOT who have been shown to desaturate to 85-90% without oxygen at rest.

At each visit the device will be applied to a participant for a maximum of 3 hours.

There will be a 10 minute period of monitoring with the participant on their normal LTOT at rest. LTOT will then be removed and NHFO2 will be applied when their SpO2 falls below 90%. The device will initially be set to 35L/min flow and 21% FiO2 at a temperature of 37C.

The FiO2 and flow rate will initially be ramped manually up and down, with a period of monitoring at each increment. FiO2 will be ramped up and down in increments of 5% up to a maximum of 41% and a minimum of 21%. There will be 6 minutes of monitoring at each increment.

After FiO2 ramping, the FiO2 will be set to maintain the participant's SpO2 between 92 and 96%. Flow will then be ramped up and down in increments of 10L/min up to a maximum of 55L/min and a minimum of 15L/min. There will be 6 minutes of monitoring at each flow increment.

The device will then be removed to allow a period of desaturation. The device will then be re-applied when the participant's SpO2 falls to below 90%, set at 21% FiO2 and 35L/min. The device will then be allowed to autotitrate the FiO2 to a target SpO2 of 92-96% both at rest and while asking participants to nose breathe, mouth breathe, talk and undertake a 6 minute walk test (6MWT).

There will initially be a 10 minute period of monitoring at rest once SpO2 is within target range of 92-96%. The tasks of nose breathing, mouth breathing and talking will then last for 2 minutes each, with a rest period of 5 minutes after each task. There will be a 10 minute period of monitoring at rest before the 6MWT and a 6 minute period of monitoring at rest after the 6MWT.

SpO2 will be monitored using a pulse oximeter associated with the NHFO2 device. This will capture data for the primary outcome variable. A SenTec device will also be used, which will capture SpO2, PtCO2 and heart rate. This data will be used for the secondary outcome variables.

If the participant's SpO2 falls to <85% or PtCO2 rises by >10mmHg above baseline at any time, that phase of the study will be aborted and the device will be set to the last FiO2 and flow at which SpO2 and PtCO2 were within acceptable range.

Participant adherence will not specifically be monitored as an investigator will be with the participant at all times. Any phase of the visit can be terminated due to participant discomfort related to the device settings.

After the first visit, each participant will be invited back for up to 5 further visits. It will be at the participant's discretion how many further visits they wish to attend. They may choose to not attend any further visits or they may choose to attend further visits, up to a maximum of 5 further visits. There will be a period of 1 to 2 weeks between visit. At each subsequent visit, some or all of the phases will be repeated depending on the device's performance. This will be determined by the investigator and the sponsor prior to each visit.

The first visit will last approximately 4 hours with each subsequent visit lasting approximately 3 hours.

The sponsor will have the opportunity to optimize the feedback algorithm between visits.
Intervention code [1] 299024 0
Treatment: Devices
Comparator / control treatment
This is an initial study to test the performance of the device hence there is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303252 0
The percentage of total time spent within the participant's SpO2 within target range of 92 to 96% while using NHFO2 in autotitration mode. The SpO2 will be measured by the pulse oximeter associated with the NHFO2 device. Time in autotitration mode will be measured by a study investigator using a stopwatch.
Timepoint [1] 303252 0
End of each visit - approximately 3 hours
Secondary outcome [1] 338425 0
SpO2: minimum, maximum, mean, % time spent <92% and >96% during each FiO2 increment of the FiO2 manual ramp phase. Measured by pulse oximeter associated with NHFO2.
Timepoint [1] 338425 0
End of each 6 minute interval for each FiO2 increment
Measured at all visits where this phase is carried out.
Secondary outcome [2] 338426 0
PtCO2: minimum, maximum, mean during each FiO2 increment of the FiO2 manual ramp phase. Measured by SenTec device.
Measured at all visits where this phase is carried out.
Timepoint [2] 338426 0
End of each 6 minute interval for each FiO2 increment.
Measured at all visits where this phase is carried out.
Secondary outcome [3] 338428 0
Heart rate: minimum, maximum, mean during each FiO2 increment of the FiO2 manual ramp phase. Measured by SenTec device.
Timepoint [3] 338428 0
End of each 6 minute interval for each FiO2 increment
Measured at all visits where this phase is carried out.
Secondary outcome [4] 338431 0
SpO2: minimum, maximum, mean, % time spent <92% and >96% during each flow increment of the flow manual ramp phase. Measured by pulse oximeter associated with NHFO2.
Timepoint [4] 338431 0
End of each 6 minute interval for each flow increment.
Measured at all visits where this phase is carried out.
Secondary outcome [5] 338432 0
PtCO2: minimum, maximum, mean during each flow increment of the flow manual ramp phase. Measured by SenTec device.
Timepoint [5] 338432 0
End of each 6 minute interval for each flow increment
Measured at all visits where this phase is carried out.
Secondary outcome [6] 338433 0
Heart rate: minimum, maximum, mean during each flow increment of the flow manual ramp phase. Measured by SenTec device.
Timepoint [6] 338433 0
End of each 6 minute interval for each flow increment.
Measured at all visits where this phase is carried out.
Secondary outcome [7] 338434 0
The percentage of time spent within the SpO2 target range of 92 to 96% while using NHFO2 with autotitration at rest, during 6 minute walk test (6MWT), nose breathing, mouth breathing and talking. Measured by pulse oximeter associated with NHFO2.
Timepoint [7] 338434 0
End of autotitration at rest phase, end of 6MWT, end of nose breathing with autotitration, mouth breathing with autotitration and talking with autotitration phases respectively.
Measured at all visits where this phase is carried out.
Secondary outcome [8] 338435 0
SpO2: minimum, maximum, mean, % time spent <92% and >96% at rest, during 6MWT, nose breathing, mouth breathing and talking while using NHFO2 with autotitration. Measured by pulse oximeter associated with NHFO2.
Timepoint [8] 338435 0
End of autotitration at rest phase, end of 6MWT, end of nose breathing with autotitration, mouth breathing with autotitration and talking with autotitration phases respectively.
Measured at all visits where this phase is carried out.
Secondary outcome [9] 338436 0
Estimated FiO2: minimum, maximum, mean estimated FiO2, and percentage of time >21% at rest, during 6MWT, nose breathing, mouth breathing and talking while using NHFO2 with autotitration. Measured by NHFO2.
Timepoint [9] 338436 0
End of autotitration at rest phase, end of 6MWT, end of nose breathing with autotitration, mouth breathing with autotitration and talking with autotitration phases respectively.
Measured at all visits where this phase is carried out.
Secondary outcome [10] 338438 0
Heart rate: minimum, maximum and mean at rest, during 6MWT, nose breathing, mouth breathing and talking while using NHFO2 with autotitration and during manual ramp phase. Measured by SenTec device.
Timepoint [10] 338438 0
End of autotitration at rest phase, end of 6MWT, end of nose breathing with autotitration, mouth breathing with autotitration and talking with autotitration phases respectively.
Measured at all visits where this phase is carried out.
Secondary outcome [11] 338439 0
PtCO2: minimum, maximum and mean at rest, during 6MWT, nose breathing, mouth breathing and talking while using NHFO2 with autotitration. Measured by SenTec device.
Timepoint [11] 338439 0
End of autotitration at rest phase, end of 6MWT, end of nose breathing with autotitration, mouth breathing with autotitration and talking with autotitration phases respectively.
Measured at all visits where this phase is carried out.
Secondary outcome [12] 338440 0
6MWT distance achieved. Measured by investigator as meters achieved after 6 minutes or when participant is unable to walk further.
Timepoint [12] 338440 0
End of 6MWT
Measured at all visits where this phase is carried out.

Eligibility
Key inclusion criteria
1) Adults over the age of 18 with a doctor’s diagnosis of a chronic respiratory disease, such as COPD, bronchiectasis or interstitial lung disease, who are prescribed long term oxygen therapy (LTOT).
2) Participant's SpO2 85-90% without oxygen.
3) Participant's respiratory condition must have been stable with no exacerbations within the last 4 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Age <18
2) Any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results.
3) Diagnosis of a notifiable disease
4) The presence of an implantable Medical Device
5) Inability to tolerate an interruption in oxygen therapy
6) Requirement for more than 4L/min LTOT at rest
7) Unstable angina or myocardial infarction within the previous month

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
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
Safety/efficacy
Statistical methods / analysis
As this is a study designed to optimise the feedback algorithm for a medical device, no power calculation has been undertaken for statistical significance.

For the primary outcome variable, the proportion of total time spent with a SpO2 92-96% while using NHFO2 in autotitration mode, will be calculated and expressed along with 95% confidence intervals.

For secondary outcome variables, minimum, maximum and mean values will be calculated using data output from the NHFO2 device and the SenTec device.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/12/2017
Actual
21/12/2017
Date of last participant enrolment
Anticipated
30/03/2018
Actual
24/04/2018
Date of last data collection
Anticipated
19/05/2018
Actual
29/06/2018
Sample size
Target
12
Accrual to date
Final
12
Recruitment outside Australia
Country [1] 9175 0
New Zealand
State/province [1] 9175 0
Wellington

Funding & Sponsors
Funding source category [1] 297416 0
Commercial sector/Industry
Name [1] 297416 0
Fisher and Paykel Healthcare Limited
Country [1] 297416 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare Limited
Address
15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand. Auckland 2013.
Country
New Zealand
Secondary sponsor category [1] 296409 0
None
Name [1] 296409 0
Address [1] 296409 0
Country [1] 296409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298521 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 298521 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 298521 0
New Zealand
Date submitted for ethics approval [1] 298521 0
14/09/2017
Approval date [1] 298521 0
21/11/2017
Ethics approval number [1] 298521 0
17/STH/186

Summary
Brief summary
Patients with chronic respiratory disorders who are hypoxic at rest may have limited exercise capacity due to critical oxygen desaturation on exertion. Patients who desaturate during exercise have an increased risk of mortality. Delivering fixed concentrations of oxygen via nasal high flow (NHF) therapy during exercise has already been shown to improve exercise time in COPD. However, a preferable method of oxygen delivery would involve titration of varying concentrations of oxygen to achieve an optimal SpO2 range which would have the advantages not only of increased safety, but also improved exercise capacity.

The nasal high flow oxygen titration device (NHFO2) is a novel device which is able to automatically titrate the amount of oxygen delivered to achieve a target oxygen saturation via a closed feedback loop mechanism.

This is a study designed to test and optimize the algorithm used by NHFO2 for automatic oxygen titration.

Patients who are normally on LTOT and who desaturate to 85-90% off oxygen will be using NHFO2 both at rest and during a 6MWT. This will provide an appropriate level of desaturation to test the autotitration algorithm of NHFO2.

NHFO2 will be used both in manual and autotitration mode to gain as much feedback about device performance as possible.

Data regarding participant SpO2, PtCO2, heart rate and FiO2 delivered will be collected and analysed. Participants will be invited back for up to a total of six sessions. The sponsor will have the opportunity to optimize the device algorithm between visits based upon the data collected.

Further trials assessing the efficacy of the device are planned once the autotitration feedback algorithm has been shown to be effective.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77342 0
Dr Irene Braithwaite
Address 77342 0
Medical Research Institute of New Zealand
Level 7, Clinical Services Building,
Wellington Regional Hospital,
Newtown, Wellington 6021
New Zealand
Country 77342 0
New Zealand
Phone 77342 0
+64 4 8050245
Fax 77342 0
Email 77342 0
[email protected]
Contact person for public queries
Name 77343 0
James Harper
Address 77343 0
Medical Research Institute of New Zealand
Level 7, Clinical Services Building,
Wellington Regional Hospital,
Newtown, Wellington 6021
New Zealand
Country 77343 0
New Zealand
Phone 77343 0
+64 4 8050232
Fax 77343 0
Email 77343 0
[email protected]
Contact person for scientific queries
Name 77344 0
James Harper
Address 77344 0
Medical Research Institute of New Zealand
Level 7, Clinical Services Building,
Wellington Regional Hospital,
Newtown, Wellington 6021
New Zealand
Country 77344 0
New Zealand
Phone 77344 0
+64 4 8050232
Fax 77344 0
Email 77344 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.