None listed
Conditions
Brief summary
Preoxygenation is a process which occurs prior to anaesthetising patients prior to surgery. Preoxygenation is a difficult process as it requires placing a mask over a patient’s nose and mouth and creating an air tight seal forcing oxygen from the anaesthetic circuit into the patient’s lungs. The OxyFriend is a novel silicone device which was designed to be utilized with traditional anaesthetic mask. The OxyFriend was designed to improve preoxygenation and my reduce leaking during preoxygenation. The study aims to test whether the OxyFriend will make the process of preoxygenation more effective. A secondary aim to is test whether the OxyFriend will reduce the leakage around the anaesthetic mask.
Interventions
The Oxyfriend is a device consist of a small moulded silicone bridge which is used to secure the nasal cannula under the anaesthetic mask and improve oxygenation. The interventions will consist of comparing oxygenation of awake subjects utilising 100% oxygen and comparing the effectiveness of oxygenation between the anaestehtic mask arm and the anaesthetic mask plus Oxyfriend arm. The constant in this experiment will be that the investigator will be conducting both arms of the experiment so that
The Oxyfriend is a device consist of a small moulded silicone bridge which is used to secure the nasal cannula under the anaesthetic mask and improve oxygenation. The interventions will consist of comparing oxygenation of awake subjects utilising 100% oxygen and comparing the effectiveness of oxygenation between the anaestehtic mask arm and the anaesthetic mask plus Oxyfriend arm. The constant in this experiment will be that the investigator will be conducting both arms of the experiment so that preoxygenation technique is not altered. The data will be collected over 6 separate interventions which will be held back to back with a rest in between to allow normalisation of oxygenation of the subjects, 2 minute duration. The three interventions in this arm will be : 1. Anaesthetic mask 2. Anaesthetic mask and nasal cannula 3. Anaesthetic mask nasal cannula and Oxyfriend The data will be collected, which is the end title oxygen after two vital capacity breaths, this will take 1 minute. The estimated overall time of data collection will be around 10 minutes. We will also be conducting a leak test which will conducted after the oxygenation portion and this will consist of all three arms: 1. Anaesthetic mask 2. Anaesthetic mask and nasal prong 3. Anaesthetic, nasal prong and the oxyfriend The nasal prongs blocked at the oxygen connector end so that no flow occurs through the prongs during the test. The anaesthetic machine will be turned on and the circuit set to the ventilator setting with 4cm water PEEP and 2cm water pressure support. The anaesthetic mask is placed on the participant by the researcher to obtain the optimum seal possible. At the end of 1 minute of normal inspiration tidal volume will be measured and this will allow us to extrapolate the amount leakage which will occur in each arm. The investigator, an intern, will be administering the intervention and will be observed by a specialist anaesthetist and they will make sure all equipment is used appropriately.
Sponsors
Northeast Health Wangaratta
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
Yes
Inclusion criteria
Voluntary, healthy adult participants from staff and students at Northeast Health Wangaratta.
Exclusion criteria
age less than 18 years old, presence of relevant co-morbidities such as airway disease (including but not limited to: asthma and COPD), factors that may cause leak such as beards and facial abnormalities. Prior exposure to the drugs amiodarone and bleomycin.
Outcome results
None listed