None listed
Conditions
Brief summary
This single-center, prospective study aims to iteratively assess and improve the reliability of exhaled carbon dioxide sampling in participants receiving high-flow nasal oxygen (HFNO) during gastrointestinal endoscopy procedures. The investigational device is a CO2 sampling device that will sample and measure expired CO2. There is no hypothesis to be tested as this study is an exploratory study.
Interventions
The investigational device is an exhaled CO2 sampling device (CO2-sampler) connected to a capnograph. The CO2-sampler is attached to nasal prongs delivering standard HFNO. The participant will be fitted with the investigational device by the clinical team immediately before the procedure. The investigational device will be on the participant throughout their endoscopic procedure (ranging from 15 mins to 1 hour). Each participant will have the investigational device in situ during their endoscopy procedure only, the investigational device will not be used during any other part of their hospital stay. The anaesthetist will closely observe and monitor the participant throughout their procedure. Adherence to the study will be closely observed by a study team member and notes will be recorded on the study CRF. Different iterations of the investigational device will be included in the study, with each new iteration available approximately 2 months after the use of the first iteration. The first iteration of the sampling device has four small capnography sampling tubes that are attached to HFNO prongs so that there is a sampling tube near each nostril and at each side of the mouth. Subsequent iterations of the sampling device are not predefined and will be modified based on the data collected from the first iteration. All subsequent iterations will include HFNO prongs with one or more capnography samping lines attached positioned near the participants mouth or nose. It is anticipated approximatley five iterations will be included and each will be studied in between 5 and 20 participants.
Sponsors
Study design
Eligibility
Inclusion criteria
- Adult participants (aged 16 years or above) - Undergoing gastrointestinal (GI) endoscopy procedures under anaesthetist-led sedation - Participant's anaesthetist willing to use HFNO for the case - Willing and able to provide informed consent
Exclusion criteria
- Any underlying medical condition that, in the opinion of the participant's clinicians, will be unfavourable for the administration of the oxygen flows specified in the protocol or may impair compliance with the conduct of the investigation