RecruitingACTRN12619000292178

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

Sponsor

Dr Charles Cartwright

Enrollment

80 participants

Start Date

May 28, 2018

Study Type

Interventional

Conditions

Oxygenation during transbronchial biopsy Lung transplant patients

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.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Lung transplant recipients require regular bronchoscopy procedures — where a flexible camera is passed through the airways — to check for complications such as rejection or infection. These procedures are typically performed under sedation, and patients sometimes experience drops in their oxygen levels (called desaturations) during the procedure. Standard care uses low-flow oxygen delivered through nasal prongs, but this may not always keep oxygen levels high enough. High-flow nasal cannula (HFNC) therapy delivers warm, humidified oxygen at much higher flow rates and has been shown to improve oxygenation in various other clinical situations. This trial is testing whether using HFNC during bronchoscopy procedures in lung transplant patients reduces the frequency and duration of oxygen desaturations and the need for additional airway interventions. You may be eligible if you are 18 or older, have received a lung transplant, are scheduled for a transbronchial biopsy procedure at the study site, and are able to communicate in English. People with active respiratory or cardiovascular failure, recent pneumothorax, significant nasal problems that would prevent nasal oxygen delivery, or those who require general anaesthesia with a breathing tube for the procedure would not be eligible.

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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 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.

Locations(1)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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ACTRN12619000292178