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 AIRVO3. The main aim of the study is to find out whether automatic oxygen adjustment by the AIRVO3 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 24 hours.
Interventions
Nasal High Flow therapy using the AIRVO3 device with automatic oxygen titration
Participants will be randomised prior to extubation by study investigators with a minimum of 2 years clinical experience. The AIRVO3 device will be set up on automatic oxygen titration mode and will be used by trained doctors and nurses in the intensive care unit. A pulse oximeter sensor will be attached to the participant's finger which will provide feedback to the AIRVO3 device. In addition to monitoring SpO2 via
Nasal High Flow therapy using the AIRVO3 device with automatic oxygen titration Participants will be randomised prior to extubation by study investigators with a minimum of 2 years clinical experience. The AIRVO3 device will be set up on automatic oxygen titration mode and will be used by trained doctors and nurses in the intensive care unit. A pulse oximeter sensor will be attached to the participant's finger which will provide feedback to the AIRVO3 device. In addition to monitoring SpO2 via the AIRVO3, the patient will have SpO2 monitored using a standard ICU pulse oximeter. The AIRVO3 device will be set to automatic oxygen titration mode with a target SpO2 between 92 and 96%. A study investigator will set the initial FiO2 to maintain SpO2 within target range. The FiO2 which maintains the participant’s SpO2 at the mid-point of the target range (94%) will be set as the mid-point for the appropriate FiO2 range. For example, if 0.30 FiO2 was required to maintain and SpO2 of 94% for a participant with the target SpO2 of 92-96%, the FiO2 range 0.25-0.35 would be selected. Participants randomised to automatic oxygen titration will receive NHF therapy using the AIRVO3 device with automatic oxygen titration until whichever of the following occurs first: FiO2 at 0.21 for one continuous hour, 24 hours therapy, SaO2 of clinical concern when the SpO2 recorded on the AIRVO3 device is within the target range, or discharge from ICU, or withdrawn from the study. All other aspects of medical care will continue as usual during the study period.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Elective cardiac surgery with postoperative ICU care - Deemed clinically ready for extubation in the ICU following cardiac surgery - Target SpO2 of 92-96% documented by clinical team - PaO2/FiO2 ratio of <350 prior to extubation
Exclusion criteria
• Age < 18 • 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 • There is a discrepancy between the arterial blood oxygen saturation level with the SpO2 value which is of clinical concern prior to extubation • Evidence of respiratory infection or colonization with multidrug resistant bacteria, Pseudomonas species, Burkholderia Cepacia or mycobacteria • Patient not expected to survive hospital admission or being treated with palliative intent • Nasal or facial conditions precluding use of NHF • Intracranial trauma or trans-nasal neurosurgery (within 6 weeks) • Any condition which limits the feasibility of continuous SpO2 monitoring using a finger probe such as anatomical deformity or vascular compromise • 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
Outcome results
None listed