None listed
Conditions
Brief summary
This study is investigating a new oxygen delivery device which automatically adjusts the amount of oxygen it gives. A finger sensor is connected to the device and continuously measures the amount of oxygen in the blood. Based on this measurement, the device can increase or decrease the amount of oxygen to keep blood oxygen levels in the correct range. The device has been developed by Fisher and Paykel Healthcare (FPH) and is called Airvo 3. The main aim of the study is to find out whether automatic oxygen adjustment by the Airvo 3 device keeps blood oxygen levels in the correct range for a greater amount of time compared to the usual way of adjustment by doctors and nurses. We will test this over a period of 3 hours while the patients are in the emergency department.
Interventions
Participants randomised to automatic oxygen titration will receive nasal high flow oxygen therapy using the Airvo 3 device for up to a maximum of 3 hours duration of oxygen treatment in the emergency department.
A study investigator will set up the Airvo 3 device and will train ED staff on how to use the device. The study investigator will be available at all times during the treatment period to support the study intervention.
The Airvo 3 device will be set to automatic titration mode with a ta
Participants randomised to automatic oxygen titration will receive nasal high flow oxygen therapy using the Airvo 3 device for up to a maximum of 3 hours duration of oxygen treatment in the emergency department. A study investigator will set up the Airvo 3 device and will train ED staff on how to use the device. The study investigator will be available at all times during the treatment period to support the study intervention. The Airvo 3 device will be set to automatic titration mode with a target SpO2 between 92 and 96% or 88 and 92%. The study investigator will set the initial FiO2 to maintain SpO2 within target range. A low and high SpO2 alarm will be set to prompt protocol compliance. In the event of a requirement for escalation of FiO2, the device will automatically increase the FiO2 to maintain SpO2 in target range. The FiO2 will only increase to the set upper FiO2 limit. When the device reaches this FiO2 upper limit, an alarm will sound. This will prompt the participant's nurse and study investigator to adjust the parameters and/or arrange medical review. In the event of a requirement for escalation of FiO2 to maintain SpO2 within the target range, and the FiO2 is increased to above the upper limit of 0.40 in those with an 88-92% target range, and above the upper FiO2 limit of 0.50 in those with a 92-96% target range, for more than 10 minutes, the participant will be withdrawn The randomised study treatment is completed if the patient has received nasal high flow oxygen therapy using the Airvo 3 device for a maximum of 3 hours , or if randomised treatment is stopped for a clinical indication, whichever occurs first. Such indications may include the patient being weaned off oxygen therapy, transferred to an alternative method of oxygen delivery or discharged from the emergency department.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: Target SpO2 92-96% • Target SpO2 of 92-96% appropriate (not at risk of hypercapnic respiratory failure) • Expected duration of oxygen therapy >1 hour Inclusion Criteria: Target SpO2 88-92% • Target SpO2 of 88-92% appropriate (risk of hypercapnic respiratory failure) • Expected duration of oxygen therapy >1 hour
Exclusion criteria
Common Exclusion Criteria • Age < 18 • Haemodynamic instability (systolic blood pressure <90mmHg or requirement for vasopressor or inotropic support) • Documented respiratory acidosis at the time of enrolment (pH <7.35 and PCO2 >45mmHg). • Patient receiving end of life care • Risk of barotrauma, as assessed by the investigator • Nasal or facial conditions precluding use of NHF • Intracranial trauma or trans-nasal neurosurgery (within 6 weeks) • Pregnancy or breastfeeding • Cognitive impairment or impaired consciousness precluding informed consent • 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 Exclusion Criteria: Target SpO2 92-96% • Requirement for > 50% FiO2 to achieve an SpO2 between 92-96% at time of enrolment (> 8L/min Hudson mask) • Presence of any risk factor for hypercapnic respiratory failure including: COPD, cystic fibrosis, bronchiectasis, chest wall deformity or neuromuscular disease AND investigator considers 92-96% to be an inappropriate SpO2 target. Exclusion Criteria: Target SpO2 88-92% • Requirement for > 40% FiO2 at time of enrolment (equivalent to 5L/min nasal prongs) Patients with a target SpO2 range of 88-92% and compensated hypercapnia will be eligible for inclusion, however those with a respiratory acidosis will be excluded from the study. Participants who meet all inclusion and are not excluded by the above criteria will proceed to complete a further screening intervention (see public notes for description). If the participant requires <0.24 FiO2 after this 10 minute screening intervention, the participant will be excluded.
Outcome results
None listed