None listed
Conditions
Brief summary
Oxygen therapy is used extensively worldwide across a broad spectrum of both acute and chronic illness. The harmful effects of hypoxaemia are common knowledge, however it is becoming increasingly recognised that hyperoxia can also be harmful in a number of settings. It is therefore important that patients who receive oxygen, receive the correct amount. Adjustment of inspired oxygen is difficult and time consuming, which leads to patients spending significant portions of time with an oxygen saturation (SpO2) that is either too high or too low. This is of particular significance for patients with chronic lung disease. NHFO2 is a novel nasal high-flow oxygen delivery device designed to automatically adjust the delivered oxygen concentration to keep SpO2 within a target range. The device delivers warmed, humidified gas at high flow through a nasal cannula. Oxygen is blended into the gas mixture to achieve a variable concentration of delivered oxygen. The device receives feedback from a pulse oximeter in order to adjust the delivered oxygen concentration to achieve a desired oxygen saturation range using a closed-loop control mechanism. This is a single-blind, randomised, 3-way cross-over trial, involving participants with chronic respiratory disease such as chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD) and bronchiectasis. All participants will have shown a fall in SpO2 to below 90% during a 6MWT at visit one. The primary aim of the trial is to examine the efficacy of the closed-loop feedback system in participants with chronic respiratory disorders, during a 6-minute walk test (6MWT). The study comprises two visits; an initial visit of around 1 hour to gain informed consent and assess eligibility and a second visit of around 3 hours to undertake three 6MWT tests. The 6MWTs will be performed i) using NHFO2 with closed-loop oxygen control with a target SpO2 of 92-96% ii) using NHFO2 set to deliver a fixed FiO2 of 21% iii) using NHFO2 set to deliver a fixed FiO2 of 28%. The order of the interventions during the three 6MWTs will be random. The primary outcome is the difference in proportion of time spent with SpO2 92-96% during the 6MWT between the interventions.
Interventions
This is a study to assess the efficacy of a novel nasal high-flow oxygen delivery device (NHFO2) in participants with stable chronic respiratory disease who desaturate during a six-minute walk test (6MWT). The device is able to automatically adjust the delivered oxygen concentration to achieve a desired oxygen saturation (SpO2) range using feedback from a pulse oximeter and a closed-loop control mechanism. We have recently completed a related study designed to test and optimize the algorithm use
This is a study to assess the efficacy of a novel nasal high-flow oxygen delivery device (NHFO2) in participants with stable chronic respiratory disease who desaturate during a six-minute walk test (6MWT). The device is able to automatically adjust the delivered oxygen concentration to achieve a desired oxygen saturation (SpO2) range using feedback from a pulse oximeter and a closed-loop control mechanism. We have recently completed a related study designed to test and optimize the algorithm used in the closed-loop control mechanism in participants who are hypoxaemic at rest (ACTRN12617001278325). In this study, participants with chronic respiratory disease, without resting hypoxaemia, who have been shown to desaturate <90% during a screening 6MWT will undertake three 6MWTs with the following interventions: 1) Using the NHFO2 device at a fixed inspired oxygen concentration (FiO2) of 28% at 35L/min flow 2) Using the NHFO2 device at a fixed inspired oxygen concentration (FiO2) of 21% at 35L/min flow 3) Using the NHFO2 device with FiO2 titrated by closed-loop control to maintain SpO2 92-96% at 35L/min flow Participants will undertake each 6MWT at MRINZ. A Masimo RD SET Adt sensor will be attached to a finger, which will provide feedback to the NHFO2 device. Heart rate and SpO2 will be recorded by the NHFO2 device via the Masimo finger sensor. A Bitmos sat 801+ pulse oximeter will also record SpO2 and heart rate and via a second Masimo RD SET Adt sensor attached to a different finger. High-flow gas will be delivered by an Optiflow nasal cannula attached to a heated breathing tube. The NHFO2 device, data recording tablet, Bitmos pulse oximeter and an "A" size medical oxygen bottle will be attached to a mobile stand which will be pushed behind the participant by a study investigator during the walk test. There will be a period of 2 minutes of monitoring prior to each intervention with the participant breathing room air and seated comfortably. The 6MWT will then be undertaken as per ATS guidelines. Each 6MWT can be stopped at any time at the participant’s request. In addition, as per ATS guidelines, the test will be stopped immediately for any of the following: chest pain, intolerable dyspnea, leg cramps, staggering, diaphoresis and pale or ashen appearance. Exertional activity will be stopped and supplemental oxygen will be applied by the investigator as necessary. The participant will be closely monitored to ensure recovery and normalization of physiological parameters. If the participant’s SpO2 falls to <80% during any 6MWT, that 6MWT will be terminated. Supplemental oxygen will be applied as necessary and the participant will be closely monitored to ensure SpO2 returns to baseline. There will be a 10 minute period of monitoring after the 6MWT with the participant seated, using the same method of oxygen delivery as during the 6MWT. The order of interventions will be random and participants will be blinded to each intervention. There will be a 60 minute rest period between each 6MWT with the participant breathing room air to allow physiological parameters to normalize and the effect of any oxygen therapy to wash out. A study investigator will be present with the participant throughout the duration of the study. All study investigators will be fully qualified medical practitioners.
Sponsors
Fisher and Paykel Healtcare
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Doctor’s diagnosis of chronic respiratory disease, such as chronic obstructive pulmonary disease (COPD), interstitial lung disease or bronchiectasis • Age >18 years • SpO2 <90% during 6 minute walk test, demonstrated at visit one. • Stable respiratory state with no exacerbation in last 4 weeks
Exclusion criteria
• Requirement for long term oxygen therapy (LTOT) or SpO2 <92% at rest • Presence of any absolute or relative (at investigator discretion) contraindications to 6 minute walk test as per ATS/ERS technical standard • Diagnosis of a notifiable disease • Infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria • The presence of an implantable Medical Device • 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