Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000006145
Ethics application status
Approved
Date submitted
20/12/2018
Date registered
8/01/2019
Date last updated
19/02/2021
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A study designed to test a new oxygen delivery device (NHFO2) and assess comfort of breathing in patients with long term respiratory disease
Scientific title
Algorithm feasibility of a novel oxygen delivery system using comfort mode and closed-loop oxygen control in participants with chronic lung disease
Secondary ID [1] 296601 0
None
Universal Trial Number (UTN)
U1111-1223-6230
Trial acronym
NHFO2: Algorithm 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 310437 0
Interstitial Lung Disease 310438 0
Bronchiectasis 310439 0
Condition category
Condition code
Respiratory 309153 309153 0 0
Chronic obstructive pulmonary disease
Respiratory 309154 309154 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This feasibility study will evaluate the comfort mode of the NHFO2 device both with and without closed-loop oxygen control. The device uses two internal algorithms; one related to closed-loop oxygen control and one related to comfort mode. NHFO2 is a newly developed device which delivers heated, humidified high flow oxygen via nasal cannulae. The device has a closed-loop oxygen control option where the FiO2 is automatically titrated to achieve a set patient target SpO2.

The device also has a comfort mode in which the flow is altered. This mode is hypothesized to improve user comfort. Different levels of comfort mode can be selected (0-5).

The FiO2 and flow rate can also be adjusted manually.

The device will be applied by a medically qualified study investigator. This study will involve 2 groups of participants. 3 participants will be recruited to group A. Up to 5 participants will be recruited to group B. The fidelity of the study will be monitored internally according to MRINZ Standard Operating Procedures.

GROUP A:
Group A participants will undergo a single test evaluating the comfort of the NHFO2 device at different flow rates with comfort mode enabled and disabled. Participants enrolled in Group A will be those that have a diagnosis of chronic respiratory disease who do not have resting hypoxaemia and do not require long term oxygen therapy. The first visit will be a screening visit to assess eligibility.

Potential patients will attend the MRINZ facility at Wellington Hospital for Visit 1, in which the PIS will be discussed, written informed consent will be completed, demographic data collected, baseline, weight, SpO2 and heart rate measured and spirometry completed. The screening visit will last around one hour.

If eligible, participants will be invited for a second visit, using the NHFO2 device. Participants will attend for a single testing visit with no repeat visits. At the testing visit, the participant will be allocated to Test A1 (see Table below)

Test A1: (16 runs, 48 mins)
21% FiO2 delivered at varying flow rates (L/min) and at different levels of comfort mode
Run 1 Flow 10 FiO2 21 Comfort Mode 0 Time 3
Run 2 Flow 10 FiO2 21 Comfort Mode 5 Time 3
Run 3 Flow 25 FiO2 21 Comfort Mode 0 Time 3
Run 4 Flow 25 FiO2 21 Comfort Mode 5 Time 3
Run 5 Flow 35 FiO2 21 Comfort Mode 0 Time 3
Run 6 Flow 35 FiO2 21 Comfort Mode 1 Time 3
Run 7 Flow 35 FiO2 21 Comfort Mode 3 Time 3
Run 8 Flow 35 FiO2 21 Comfort Mode 5 Time 3
Run 9 Flow 45 FiO2 21 Comfort Mode 0 Time 3
Run 10 Flow 45 FiO2 21 Comfort Mode 5 Time 3
Run 11 Flow 55 FiO2 21 Comfort Mode 0 Time 3
Run 12 Flow 55 FiO2 21 Comfort Mode 1 Time 3
Run 13 Flow 55 FiO2 21 Comfort Mode 3 Time 3
Run 14 Flow 55 FiO2 21 Comfort Mode 5 Time 3
Run 15 Flow 70 FiO2 21 Comfort Mode 0 Time 3
Run 16 Flow 70 FiO2 21 Comfort Mode 5 Time 3

During each run, participants will receive an oxygen concentration (FiO2) of 21% (room air) at a set temperature between 35-37°C as determined by participant preference, at different flow rates and at different levels of comfort mode.

At the end of each run, participants will be asked to rate their level of comfort of breathing, using a visual analogue scale. Participants will also be asked to rate the degree of noise produced by the device on a visual analogue scale after runs that test the device using flow rate of 45L/min or above.

The total duration of visit two will be a maximum of three hours. If required, at the discretion of the investigators, the test or individual runs within the test may be repeated or skipped up to a maximum testing period of 3 hours per visit.

GROUP B:
Group B participants will undergo five tests evaluating the varying modes of the NHFO2 device. Participants enrolled in Group B will be those that have a diagnosis of chronic respiratory disease who are hypoxiaemic at rest and are prescribed long-term oxygen therapy. This will allow closed-loop oxygen control to be tested in these participants at rest.

The first visit will be a screening visit to assess eligibility and determine target SpO2 range.
Potential patients will attend the MRINZ facility at Wellington Hospital for visit one in which the PIS will be discussed, written informed consent will be completed, demographic data collected, baseline height and weight measured, transcutaneous CO2, SpO2, heart rate measured and spirometry completed. The duration of the screening visit will be approximately one and a half hours.

The second visit will be for testing the NHFO2 device. Each participant will be allocated one or more of the five tests B1-5 (see below), up to a maximum visit duration of 3 hours. The allocation will be at the discretion of the sponsor, and will be decided in advance of the second visit. The tests will be allocated depending upon the sponsor's requirement to test different flow rates, FiO2 and comfort modes in order to optimize their device and algorithm development. If required, at the discretion of the investigators or sponsor, each test or individual runs within each test may be repeated or skipped up to a maximum testing period of 3 hours per visit.

At the end of each run, participants will be asked to rate their level of comfort of breathing, using a visual analogue scale. Participants will also be asked to rate the degree of noise produced by the device on a visual analogue scale after run 5 and 8 in Test B1 and runs 7-10 in Test B5. Participants can be requested to return for up to one further testing visit if required to make a total of 5 testing visits among group B participants.

A summary of the 5 tests are described below:
Test B1: (8 runs, 48 mins)
21% FiO2 delivered at varying flow rates (L/min) and at different levels of comfort mode

Run 1 Flow 35 FiO2 21% Comfort Mode 0 Time 6
Run 2 Flow 35 FiO2 21% Comfort Mode 1 Time 6
Run 3 Flow 35 FiO2 21% Comfort Mode 3 Time 6
Run 4 Flow 35 FiO2 21% Comfort Mode 5 Time 6
Run 5 Flow 55 FiO2 21% Comfort Mode 0 Time 6
Run 6 Flow 55 FiO2 21% Comfort Mode 1 Time 6
Run 7 Flow 55 FiO2 21% Comfort Mode 3 Time 6
Run 8 Flow 55 FiO2 21% Comfort Mode 5 Time 6

Test B2: (10 runs, 60 mins)
Manual ramping of FiO2 at fixed flow rate (L/min) with comfort mode disabled and enabled

Run 1 Flow 35 FiO2 21 Comfort Mode 0 Time 6
Run 2 Flow 35 FiO2 21 Comfort Mode 5 Time 6
Run 3 Flow 35 FiO2 26 Comfort Mode 0 Time 6
Run 4 Flow 35 FiO2 26 Comfort Mode 5 Time 6
Run 5 Flow 35 FiO2 31 Comfort Mode 0 Time 6
Run 6 Flow 35 FiO2 31 Comfort Mode 5 Time 6
Run 7 Flow 35 FiO2 36 Comfort Mode 0 Time 6
Run 8 Flow 35 FiO2 36 Comfort Mode 5 Time 6
Run 9 Flow 35 FiO2 41 Comfort Mode 0 Time 6
Run 10 Flow 35 FiO2 41 Comfort Mode 5 Time 6

Test B3: (2 runs, up to 2 hours)
Closed-loop control of SpO2 at fixed flow (L/min) with comfort mode disabled and enabled

Run 1 Flow 35 FiO2 Closed-loop Comfort Mode 0 Time upto 60
Run 2 Flow 35 FiO2 Closed-loop Comfort Mode 5 Time upto 60

Test B4: (9 runs, 21 mins)
Closed-loop control of SpO2, delivered at 35L/min with comfort mode disabled and enabled while mouth breathing, nose breathing and talking

Run 1 Flow 35 FiO2 Closed-loop Comfort Mode 0 Breathing Activity Mouth, Time 2
Run 2 Flow 35 FiO2 Closed-loop Comfort Mode 5 Breathing Activity Mouth, Time 3
Run 3 Flow 35 FiO2 Closed-loop Comfort Mode 0 Breathing Activity Rest, Time 2
Run 4 Flow 35 FiO2 Closed-loop Comfort Mode 0 Breathing Activity Nose, Time 2
Run 5 Flow 35 FiO2 Closed-loop Comfort Mode 5 Breathing Activity Nose, Time 3
Run 6 Flow 35 FiO2 Closed-loop Comfort Mode 0 Breathing Activity Rest, Time 2
Run 7 Flow 35 FiO2 Closed-loop Comfort Mode 0 Breathing Activity Talking, Time 2
Run 8 Flow 35 FiO2 Closed-loop Comfort Mode 5 Breathing Activity Talking, Time 3
Run 9 Flow 35 FiO2 Closed-loop Comfort Mode 0 Breathing Activity Rest, Time 2

Test B5: (10 runs, 60 mins)
Closed-loop control of SpO2 at different flow rates (L/min) with comfort mode disabled and enabled

Run 1 Flow 35 FiO2 Closed-loop Comfort Mode 0 Time 6
Run 2 Flow 35 FiO2 Closed-loop Comfort Mode 5 Time 6
Run 3 Flow 15 FiO2 Closed-loop Comfort Mode 0 Time 6
Run 4 Flow 15 FiO2 Closed-loop Comfort Mode 5 Time 6
Run 5 Flow 25 FiO2 Closed-loop Comfort Mode 0 Time 6
Run 6 Flow 25 FiO2 Closed-loop Comfort Mode 5 Time 6
Run 7 Flow 45 FiO2 Closed-loop Comfort Mode 0 Time 6
Run 8 Flow 45 FiO2 Closed-loop Comfort Mode 5 Time 6
Run 9 Flow 55 FiO2 Closed-loop Comfort Mode 0 Time 6
Run 10 Flow 55 FiO2 Closed-loop Comfort Mode 5 Time 6
Intervention code [1] 313249 0
Treatment: Devices
Comparator / control treatment
No control group
The two participant arms will not be compared. There is no control group. The outcome measures are designed to assess device efficacy in both groups of participants.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308132 0
Group A: Comfort scores assessed using Visual Analogue Scale
Timepoint [1] 308132 0
Group A: Immediately after each run
Primary outcome [2] 308133 0
Group B: Comfort scores assessed using Visual Analogue Scale
Timepoint [2] 308133 0
Group B: Immediately after each run
Secondary outcome [1] 354030 0
Group A: Participants’ impression of device noise levels assessed using Visual Analogue Scale
Timepoint [1] 354030 0
Group A: Immediately after each run performed with a flow rate of equal o greater than 45 L/min, on comfort mode level 0 and 5.
Secondary outcome [2] 354032 0
Group B: Participants’ impression of device noise levels assessed using Visual Analogue Scale
Timepoint [2] 354032 0
Group B: Immediately after run 5 and 8 in Test B1 and run 7-10 in Test B5
Secondary outcome [3] 354033 0
Group B: Minimum SpO2 as measured by the NHFO2 device.
Timepoint [3] 354033 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [4] 354034 0
Group B: Maximum SpO2 as measured by the NHFO2 device.
Timepoint [4] 354034 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [5] 354035 0
Group B: Mean SpO2 as measured by the NHFO2 device.
Timepoint [5] 354035 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [6] 354036 0
Group B: % of time spent within allocated SPO2 target range, as measured by NHFO2 device


Transcutaneous CO2 will be measured using a V-Sign ear clip sensor and SenTec device (SenTec, Switzerland) during the screening visit. Transcutaneous CO2 will be used to determine target SpO2 range during oxygen therapy as demonstrated below.

If Transcutaneous CO2 is > 45mmHg (hypercapnia), then SpO2 target range is 88% - 92%
If Transcutaneous CO2 is equal ot < 45mmHg (normocapnia), then SpO2 target range is 92% - 96%

Timepoint [6] 354036 0
Calculated for the duration of each run in Test B3, B4 and B5 after testing visit is completed
Secondary outcome [7] 354037 0
Group B: Minimum PtCO2 as measured by the SenTec device
Timepoint [7] 354037 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [8] 365384 0
Group B: Maximum PtCO2 as measured by the SenTec device
Timepoint [8] 365384 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [9] 365385 0
Group B: Mean PtCO2 as measured by the SenTec device
Timepoint [9] 365385 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [10] 365386 0
Group B: Minimum Heart Rate as measured by the NHFO2 device
Timepoint [10] 365386 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [11] 365387 0
Group B: Maximum Heart Rate as measured by the NHFO2 device
Timepoint [11] 365387 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [12] 365388 0
Group B: Mean Heart Rate as measured by the NHFO2 device
Timepoint [12] 365388 0
Calculated for the duration of each run after testing visit is completed
Secondary outcome [13] 365391 0
Group B: Mean respiratory rate as measured by the RespiTrace system,
Timepoint [13] 365391 0
Calculated for the duration of each run after testing visit is completed

Eligibility
Key inclusion criteria
Group A
1. Doctor’s diagnosis of a chronic respiratory disease such as COPD, bronchiectasis and Interstitial Lung Disease
2. Stable respiratory state with no exacerbation in last 4 weeks

Group B
1. Doctor’s diagnosis of a chronic respiratory disease such as COPD, bronchiectasis and Interstitial Lung Disease
2. Prescribed long term oxygen therapy (LTOT) for use at rest
3. Stable respiratory state with no exacerbation in last 4 weeks
4. Hypercapnic (PtCO2 >45mmHg), with SpO2 <88% at rest breathing room air OR Normocapnic (PtCO2 less than or equal to 45mmHg), with SpO2<92% at rest breathing room air
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Group A and B
1. Age <18
2. Cognitive impairment
3. Diagnosis of a notifiable disease (eg. hepatitis, TB, rheumatic fever, HIV, gastroenteritis)
4. The presence of an implantable Medical Device (eg. pacemaker, defibrillator, neurostimulator or insulin pump)
5. Known infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria
6. The presence of an implantable Medical Device (eg. Pacemaker, defibrillator, neurostimulator, or insulin pump).
7. 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.

Group B ONLY
1. Inability to tolerate an interruption in oxygen therapy
2. Requirement for more than 4L/min LTOT at rest

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Participants will not be aware of which settings are being used for each run of each test. This will reduce the risk of biasing participants impression of comfort of breathing and device noise at different levels of comfort mode..
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a study designed to determine efficacy and comfort of a medical device, no power calculation has been undertaken for statistical significance.

For the primary outcomes of both group A and group B, comfort scores will determined after each run. No formal statistical analysis will be undertaken. Comfort scores will be used to inform Fisher & Paykel regarding the tolerability of the device.

For secondary outcomes, minimum, maximum, mean of SpO2, heart rate, respiratory rate and transcutaneous CO2 will be measured.

For SpO2, the proportion of total time spent within target range while using NHFO2 in closed-loop control mode, will be calculated and expressed along with 95% confidence intervals.

Noise scores will be determined after certain runs. No formal statistical analysis will be undertaken. Noise scores will be used to inform Fisher & Paykel regarding the tolerability of the device.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/01/2019
Actual
15/04/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
6
Final
Recruitment outside Australia
Country [1] 21041 0
New Zealand
State/province [1] 21041 0
Wellington

Funding & Sponsors
Funding source category [1] 301181 0
Commercial sector/Industry
Name [1] 301181 0
Fisher and Paykel
Country [1] 301181 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel
Address
15 Maurice Paykel Place
East Tamaki, Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 300829 0
None
Name [1] 300829 0
Address [1] 300829 0
Country [1] 300829 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301921 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 301921 0
Ethics committee country [1] 301921 0
New Zealand
Date submitted for ethics approval [1] 301921 0
21/12/2018
Approval date [1] 301921 0
08/02/2019
Ethics approval number [1] 301921 0
19/STH/6

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88566 0
Dr James Harper
Address 88566 0
Medical Research Institute of New Zealand
Level 7 CSB, Wellington Hospital,
Riddiford Street, Newtown,
Wellington 6021
Country 88566 0
New Zealand
Phone 88566 0
+64 4 805 0232
Fax 88566 0
Email 88566 0
[email protected]
Contact person for public queries
Name 88567 0
James Harper
Address 88567 0
Medical Research Institute of New Zealand
Level 7 CSB, Wellington Hospital,
Riddiford Street, Newtown,
Wellington 6021
Country 88567 0
New Zealand
Phone 88567 0
+64 4 805 0232
Fax 88567 0
Email 88567 0
[email protected]
Contact person for scientific queries
Name 88568 0
James Harper
Address 88568 0
Medical Research Institute of New Zealand
Level 7 CSB, Wellington Hospital,
Riddiford Street, Newtown,
Wellington 6021
Country 88568 0
New Zealand
Phone 88568 0
+64 4 805 0232
Fax 88568 0
Email 88568 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.