None listed
Conditions
Brief summary
In some people with chronic lung and heart diseases, 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. Research studies have shown that it is important to give the correct amount of oxygen, as too little, or too much oxygen can be harmful. However, it can be difficult to give patients the right amount of oxygen, particularly as oxygen needs can vary over time. Fisher & Paykel Healthcare have developed a new device that can automatically adjust the amount of oxygen it gives, depending on how much oxygen is in the blood at the time. This device can deliver an oxygen therapy called Nasal High Flow, which involves giving a mixture of air and oxygen at a high flow through small prongs that sit just inside the nostrils. When delivering Nasal High Flow, this device has been shown to be more effective at maintaining a patient's blood oxygen levels within their target range, compared to the conventional method whereby doctors and nurses manually adjust the amount of oxygen given. The device can also deliver Non-Invasive Ventilation therapies (CPAP and Bi-level), which involve delivering pressurised air through a face mask. In CPAP mode, the device delivers continuous pressure through the mask so that the person receives the same pressure when they breathe in as when they breathe out. In the Bi-level setting, the machine delivers two different pressures: a higher pressure when the person breathes in and a lower pressure when they breathe out. The pressurised air acts on the airways and lungs to help support breathing. This study will assess if the device can effectively provide targeted oxygen delivery during non-invasive ventilation therapies, while using its automatic oxygen control function. The information obtained from this study will also help improve the technology that the device uses to provide automatically controlled oxygen.
Interventions
Non-invasive ventilation (NIV) therapies, including Bi-level spontaneous/ timed (S/T) NIV and Continuous Positive Airway Pressure (CPAP), using the Airvo 3 device with closed-loop oxygen titration and manual adjustments of the fraction of inspired oxygen (FiO2).
Participants will attend a single visit at the Medical Research Institute of New Zealand (MRINZ). During the visit, participants will complete 3 interventions in a randomised order, including Bi-level and CPAP interventions, as well as
Non-invasive ventilation (NIV) therapies, including Bi-level spontaneous/ timed (S/T) NIV and Continuous Positive Airway Pressure (CPAP), using the Airvo 3 device with closed-loop oxygen titration and manual adjustments of the fraction of inspired oxygen (FiO2). Participants will attend a single visit at the Medical Research Institute of New Zealand (MRINZ). During the visit, participants will complete 3 interventions in a randomised order, including Bi-level and CPAP interventions, as well as the comparator Nasal High Flow intervention. MRINZ staff delivering the interventions will be trained how to use the device. During the interventions, a study investigator will be present to observe the participant for safety, to adjust the settings of the device (described below), and to ensure the device is working correctly. Each intervention will follow the same protocol of an initial 15-minute rest period, a 10-minute closed-loop oxygen control period, and six manual adjustments of FiO2: During the 15-minute rest period, participants will be withdrawn from any pre-existing long term oxygen therapy, if they are receiving oxygen at baseline. Participants will then receive 10 minutes of NIV therapy while the device is set to closed-loop control with a target peripheral oxygen saturation (SpO2) range set to 92-96%. A pulse oximeter sensor will be attached to the participant's finger, which will provide feedback to the Airvo 3 device. After the 10 minutes of NIV with closed-loop oxygen control, FiO2 will be manually adjusted to the following settings: 1) Set FiO2 to 21% 2) Increase FiO2 to 25% 3) Increase FiO2 to 32% 4) Increase FiO2 to 45% 5) Decrease FiO2 to 25% 6) Decrease FiO2 to 21% Participants will receive oxygen at each of these settings for 6 minutes. For the Bi-Level S/T intervention, the device will be set at 15 cmH20 inspiratory positive airway pressure (IPAP), 5 cm expiratory positive airway pressure (EPAP), and 25°C humidity. For the CPAP intervention, the device will be set at 10 cmH20, 25°C humidity. There will be a rest period of at least 20 minutes between interventions. The total duration of the study visit is expected to be 5 hours, with assessment of each the 3 intervention / control taking approximately 1 hour, and 2 hours allocated for rest periods.
Sponsors
Medical Research Institute of New Zealand (MRINZ)
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) A doctor’s diagnosis of a chronic respiratory and/or cardiovascular disease b) Oxygen saturation measured by pulse oximetry (SpO2) of less than or equal to 90% while breathing room air
Exclusion criteria
• Age < 18 years • Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria • Risk of barotrauma, as assessed by the investigator • Nasal or facial conditions precluding use of NHF or NIV • Intracranial trauma or trans-nasal neurosurgery (within 6 weeks) • 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
Outcome results
None listed