None listed
Conditions
Brief summary
In some people with lung disease such as chronic obstructive pulmonary disease (COPD/emphysema), levels of oxygen in the blood can be low and we know that giving these people extra oxygen can help this problem and improve their health. At the moment we give a set amount of oxygen to patients which is not easy to adjust and may be too much or too little. To help this problem, a new device has been developed by Fisher and Paykel Healthcare, which is able to automatically adjust the amount of oxygen it gives, depending on blood oxygen levels at the time. The device gives a warm mixture of air and oxygen at a high flow through small prongs, which sit just inside the nostrils. Sometimes this high flow can be uncomfortable. Fisher and Paykel have therefore developed a feature called “comfort mode” which may make using the device more comfortable. This study is designed to test how well this new “comfort mode” works and whether you find it easier to breathe using this new feature.
Interventions
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 co
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
Sponsors
Fisher and Paykel
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed