None listed
Conditions
Brief summary
The purpose of this study is to validate the accuracy of the new automated respiratory rate measurement feature on the Airvo3 medical device during a respiratory support therapy called nasal high flow therapy. This study will focus on validating this measure in participants that are moving to confirm the accuracy of the measurement is maintained during light movement. It is hypothesised that the output of the respiratory rate monitoring feature is comparable to that of a gold standard benchmark or another Food and Drug Administration (FDA) approved device for continuous respiratory rate monitoring. This study will recruit 45 healthy participants and collect respiratory rate measurements from the Airvo3 medical device, a benchmark measurement, and through an FDA approved device as participants carry out 8 different movements (with each movement being carried out for 4 minutes). The accuracy of the respiratory rate measurement from the Airvo3 device will be determined by comparing measurements from the Airvo3 device with the gold-standard benchmark measurements, and measurements obtained through the FDA approved device, thus validating respiratory rate measurements from the Airvo3.
Interventions
In this study, the intervention is a new continuous respiratory rate measurement function to measure respiratory rate in people receiving therapy through the Airvo 3 medical device. The Airvo 3 device is a humidification system that delivers high flow humidified gases (air and oxygen) to patients in hospitals and sub-acute facilities. The Airvo 3 device has been updated to include a new feature (an algorithm which uses periodic changes in flow to estimate a patient’s respiratory rate) for contin
In this study, the intervention is a new continuous respiratory rate measurement function to measure respiratory rate in people receiving therapy through the Airvo 3 medical device. The Airvo 3 device is a humidification system that delivers high flow humidified gases (air and oxygen) to patients in hospitals and sub-acute facilities. The Airvo 3 device has been updated to include a new feature (an algorithm which uses periodic changes in flow to estimate a patient’s respiratory rate) for continuous monitoring of respiratory rate during high flow therapy. Healthy volunteers will be fitted with a nasal cannula to facilitate nasal high flow therapy at 20L/min through the Airvo 3 device with continuous respiratory rate monitoring capability. Participants will also be fitted with a pulse oximeter and a CO2 sampling line (attached to the nasal cannula) which will provide measurements for the validation of the respiratory rate measurement from the Airvo 3. During the trial, participants will be asked to carry out the following 8 movements while they are administered nasal high-flow and their respiratory rate is monitored: 1. Standing and breathing. 2. Walking in a circle. 3. Sitting and breathing. 4. Sitting and rotating the head every 30 seconds. 5. Sitting and rotating the torso and arms every 30 seconds. 6. Sitting and speaking for a duration of 5 seconds every 30 seconds. 7. Reclining and breathing. 8. Lying down and breathing. Each movement will be carried out for 4 minutes before switching to the next movement. All patients will carry out the movements in the order listed above with no breaks between each movement. The timing of, and instructions for, each movement will be provided by research staff. Participants will be monitored by staff over the duration of the trial visit. Therefore, research staff will ensure adherence to the study protocol during the conduct of therapy and collection of study measurements. Participants will be on the device for a maximum of 1 hour overall. The study will be conducted at the offices of a medical device company.
Sponsors
Fisher & Paykel Healthcare
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
- Participants must have the ability to understand and provide written informed consent. - Participants must be 18 years of age or older. - The participant must feel in good general health. - Participants must be able to walk and carry out required study movements without difficulty or assistance. - Participants must be able to read and write in English.
Exclusion criteria
- The participant has a previous clinical diagnosis of any chronic lung diseases including but not limited to asthma, COPD, cystic fibrosis, pulmonary fibrosis, pulmonary hypertension or congenital lung disease. - Participants who have had a cardiovascular, kidney, or liver disease. - Participants who are unable to tolerate nasal prongs. - Participants who have had abdominal/ thoracic surgery in the last 180 days. - Participants who have had any sinus or brain surgery in the last 180 days. - Participants who have presented with symptoms of an upper respiratory tract infection in the past 14 days. - Participants who have any other condition which in the opinion of investigators would make them unsuitable for the study. - Participants with severe contact allergies to standard adhesives, latex or other materials found in pulse oximetry sensors, ECG electrodes, or other medical sensors (self-reported). - Participants who refuse or are unable to sign an informed written consent for study.
Outcome results
None listed