None listed
Conditions
Brief summary
Bronchoscopy is an important diagnostic tool for many respiratory disorders. Desaturations are a common complication of bronchoscopy. Conventional low flow oxygen therapy (COT) is often used in attempt to prevent desaturations. High flow oxygen nasal oxygen (HFNO) during bronchoscopy has shown improvements in oxygenation in a number or previous studies however these studies vary significantly in their methodology and the practice has not been widely adopted. Other important considerations that have not been well studied include single cannula high flow therapy for nasal bronchoscopy procedures, procedural interruptions, cough frequency and comfort/tolerability of oxygen delivery devices during bronchoscopy. This study aims to determine whether HFNO (including a single nasal cannula option) reduces desaturations, procedure interruptions, escalation of oxygen therapy and cough frequency compared to low flow oxygen therapy during bronchoscopy (both standard and EBUS-guided). It will also evaluate whether the high flow oxygen devices studied (dual nasal cannula and single nasal cannula) are comfortable to patients and acceptable to clinicians.
Interventions
High flow nasal oxygen therapy (HFNO) via Airvo 3 device (Fisher & Paykel, Auckland New Zealand) during diagnostic bronchoscopy procedures (standard and endobronchial ultrasound guided).
Stratum one: Intention for bronchoscopy via nasal route
- Intervention: High flow nasal oxygen via single nasal cannula into one nasal cavity
Stratum two: Intention for endobronchial-ultrasound (EBUS) via oral route
- Intervention: High flow nasal oxygen via dual nasal cannula into both nasal cavities
The Ai
High flow nasal oxygen therapy (HFNO) via Airvo 3 device (Fisher & Paykel, Auckland New Zealand) during diagnostic bronchoscopy procedures (standard and endobronchial ultrasound guided). Stratum one: Intention for bronchoscopy via nasal route - Intervention: High flow nasal oxygen via single nasal cannula into one nasal cavity Stratum two: Intention for endobronchial-ultrasound (EBUS) via oral route - Intervention: High flow nasal oxygen via dual nasal cannula into both nasal cavities The Aivo3 device has a power supply and oxygen source and delivers high flow humidified air mixed with oxygen, It is connected to a single prong or dual prong nasal cannula depending on the procedure the participant is undergoing (stratum one or stratum two) and delivers the therapy via the nose with a strap around the participant's head holding the cannula in place. The difference between the interventions in each stratum is that the nasal cannula interface provides the oxygen therapy via one verus two nasal cavities. The single and dual cannula will provide the same flow rate (L/min) and oxygen concentration. The duration of the intervention is less than one hour. It includes the length of the bronchoscopy or EBUS procedure (approximately 10-25 minutes for standard bronchoscopy and 25-40 minutes for EBUS) and approximately 5 minutes pre and post procedure when the oxygen devices are attached/removed and pre-procedure sedation is given. The procedures are different between the strata with stratum one passing the bronchoscope via the nose and performing a combination of washings, brushings and endobronchial biopsies and stratum two passing the bronchoscope via the mouth and performing endobronchial ultrasound guided transbronchial needle aspirations (EBUS-TBNA). The intervention will be administered by respiratory physicians. Adherence to the intervention will be documented on a participant case report form. The starting fraction of inspired oxygen (FiO2) will be set at 28% via the Airvo 3 device and the flow rate will be set at 40L/min. The respiratory physicians performing the procedures can adjust the FiO2 throughout the procedure as required. These changes will be recorded. The flow rate will be constant.
Sponsors
Georgia Burton
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
• Age 18 years or older • Indication for diagnostic bronchoscopy (standard bronchoscopy or EBUS guided) • Pre-procedure intent to insert bronchoscope via the nose in the standard bronchoscopy group (stratum one)
Exclusion criteria
• Not able to consent • Patient is in ICU • Patient is in theatre • Patient is intubated • Patient has a tracheostomy • Pre-procedure intent to insert bronchoscope via the mouth in the standard bronchoscopy group (stratum one)
Outcome results
None listed