None listed
Conditions
Brief summary
Doctors currently examine the human gastrointestinal tract using a device called an endoscope, which contains a camera that enables the doctor to view and treat diseases from within the gastrointestinal tract. Most endoscopic procedures are done under sedation, what means that people are put asleep during such procedures by an Anaesthetist. During the examination, it is costumery that the patients' breathing capabilities become mildly impaired. For this reason, the Anaesthetists utilise supplementary oxygen to avoid the oxygen levels in your blood getting too low. Although we know that using some supplementary oxygen is better than using none, it is still under debate what is the ideal amount (or flow) of oxygen that should be used to avoid the loss of oxygenation. The purpose of this study is to determine whether two devices that deliver two different flows of oxygen (standard nasal cannula - 2 L/min or high-flow mouthguard - 20L/min) are similar or different in preventing the loss of oxygenation while under sedation for short endoscopic procedures.
Interventions
Arm 1:High-flow mouthguard (Oxyguard D® at 20L/min) as a method of oxygen delivery for low-risk for sedation patients undergoing elective short (up to 20 minutes) endoscopic procedures in an Australian tertiary hospital.
The high-flow mouthguard is a modified mouthguard which in addition to offer protection for the teeth also has an integrated oxygen delivery system. This will be used by the anaesthetist to deliver oxygen instead of the standard nasal prongs and will be used as per standard of p
Arm 1:High-flow mouthguard (Oxyguard D® at 20L/min) as a method of oxygen delivery for low-risk for sedation patients undergoing elective short (up to 20 minutes) endoscopic procedures in an Australian tertiary hospital. The high-flow mouthguard is a modified mouthguard which in addition to offer protection for the teeth also has an integrated oxygen delivery system. This will be used by the anaesthetist to deliver oxygen instead of the standard nasal prongs and will be used as per standard of practice. As per standard of practice, the device will be adapted to the mouth having the oxygen output facing the patient nostrils and secured around the neck prior to the sedation is commenced. As per standard of practice, supplementary oxygen is used throughout the whole endoscopic procedure and is maintained until the patient is fully recovered from sedation in the recovery room. The high flow will be maintained for the entire duration of the endoscopic procedure but can be brought down once the procedure has been finished and the patient sent to the recovery room, at the anaesthetist's discretion. The sedation and procedure data will be collected by one of the investigators or their delegates, in the room the endoscopic procedure is taking place.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients referred for upper gastrointestinal endoscopic procedures predicted to last less or equal to 20 minutes (e.g. diagnostic gastroscopies) • Age > 18 years • Ability to give informed consent
Exclusion criteria
• Pregnancy • Supplementary O2 dependency • Emergency procedures • Deemed by performing endoscopist as long (>20 minutes) procedure before randomisation • Patients with high risk for sedation (i.e. presence of any of the following criteria: BMI greater or equal to 35, ASA IV or Mallampati 4) • Capsule endoscopy procedure
Outcome results
None listed