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High-flow nasal oxygenation in sedated lung transplant patients during transbronchial biopsy

High-flow nasal cannula versus low-flow nasal cannula oxygenation in lung transplant patients undergoing diagnostic transbronchial biopsy: A randomised controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000292178
Enrollment
50
Registered
2019-02-26
Start date
2018-05-28
Completion date
Unknown
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Post-lung transplant bronchoscopy is a commonly performed diagnostic procedure, typically performed under sedation with Low Flow Nasal Cannula (LFNC) oxygenation. Procedural desaturations are not infrequent. Recently High Flow Nasal Cannula (HFNC) oxygenation has been demonstrated to be a safe alternative to LFNC oxygenation in a number of clinical scenarios. This trial will assess the use of HFNC oxygenation as an effective alternative to LFNC oxygenation in sedated lung transplant patients undergoing diagnostic transbronchial biopsy. We hypothesise there will be fewer, and shorter, desaturations in the HFNC group as well as fewer airway interventions.

Interventions

Post-lung transplant bronchoscopy is a commonly performed diagnostic procedure to facilitate tissue sampling for rejection and infection surveillance. Sedation is used during the procedure to optimise procedural conditions and patient comfort. Oxygenation is routinely provided by standard nasal cannula at flow rates of 4-10L/min. However procedural desaturations are not infrequent. This not only represents an obvious risk to the patient but, due to the shared airway, can also prolong the procedu

Post-lung transplant bronchoscopy is a commonly performed diagnostic procedure to facilitate tissue sampling for rejection and infection surveillance. Sedation is used during the procedure to optimise procedural conditions and patient comfort. Oxygenation is routinely provided by standard nasal cannula at flow rates of 4-10L/min. However procedural desaturations are not infrequent. This not only represents an obvious risk to the patient but, due to the shared airway, can also prolong the procedure if bronchoscopy must be halted whilst the patient is ventilated. Recently high flow nasal cannula (HFNC) has been investigated as a safe alternative to standard low flow oxygenation via nasal cannula (LFNC) during endobronchial ultrasound under conscious sedation. HFNC, delivering 30-70L/min of humidified oxygen, improved the lowest recorded oxygen saturation during the procedure. However, this method has not been trialled in lung transplant patients undergoing transbronchial biopsy. This trial will assess the use of HFNC oxygenation as a safe and effective alternative to LFNC oxygenation in sedated lung transplant patients undergoing diagnostic transbronchial biopsy. Patients will be randomised to either the intervention, HFNC, or control, LFNC, group. The participant, research assistant and bronchoscopist will all be blinded to the intervention. For both practical and safety reasons, the Anaesthetist will not be blinded. The anaesthetist will be responsible for opening the sealed envelope and ensuring the participant receives the correct oxygen flow rate. All participants will receive a standardised anaesthetic consisting of pre-oxygenation (at 4 litres/minute via nasal cannula), premedication with midazolam and alfentanil, topicalisation to the airway with a lidocaine nebuliser and ongoing sedation via a propofol infusion by Target-Controlled Infusion. The anaesthetic will be delivered by one of three senior consultant anaesthetists experienced in providing sedation for bronchoscopies using this method. High flow nasal cannula oxygenation (flow rates of 30-50L/min) will be delivered throughout the bronchoscopy (for approximately 30-60 minutes), in the operating, using the Optiflow Nasal High Flow Cannula (Fisher & Paykel, Auckland New Zealand). The flow rates will be set at the start of the procedure and may be adjusted at the discretion of the treating anaesthetic consultant.

Sponsors

Dr Charles Cartwright
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Aged >=18 years old Lung transplant patients Undergoing transbronchial biopsy English speaking and able to provide informed consent

Exclusion criteria

Aged <18 years old Non-lung transplant patients Participants not having transbronchial biopsies conducted Non-English speaking and unable to provide informed consent Pre-procedure: respiratory failure/cardiovascular failure/recent pneumothorax (<2 weeks) Chest tube in-situ Reduced level of consciousness Pregnant women Unable to have the procedure carried out with a propofol infusion Significant aspiration risk (e.g. gastroparesis/severe GORD) or unable to have the procedure done without endotracheal intubation Unsuitable for nasal cannulae – recent nasal surgery/epistaxis, significant nasal or sinus issue, marked septal deviation, basal skull fracture Clinical need for an LMA/intubation

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026