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Trial registered on ANZCTR


Registration number
ACTRN12619000292178
Ethics application status
Approved
Date submitted
22/02/2019
Date registered
26/02/2019
Date last updated
26/02/2019
Date data sharing statement initially provided
26/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
High-flow nasal oxygenation in sedated lung transplant patients during transbronchial biopsy
Scientific title
High-flow nasal cannula versus low-flow nasal cannula oxygenation in lung transplant patients undergoing diagnostic transbronchial biopsy: A randomised controlled trial
Secondary ID [1] 294518 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung transplant patients 307290 0
Oxygenation during transbronchial biopsy 311733 0
Condition category
Condition code
Anaesthesiology 306407 306407 0 0
Anaesthetics
Respiratory 306408 306408 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313725 0
Treatment: Devices
Comparator / control treatment
Low flow nasal cannula oxygenation (flow rates of 4-10L/min) will be delivered throughout the bronchoscopy (for approximately 30-60 minutes), in the operating, using standard 'wall oxygen'. The flow rates will be set at the start of the procedure and may be adjusted at the discretion of the treating anaesthetic consultant.
Control group
Active

Outcomes
Primary outcome [1] 319181 0
The proportion of participants experiencing a desaturation (defined as SpO2 <94%)
Timepoint [1] 319181 0
At any point during the bronchoscopy - from the point that the monitoring equipment (including pulse oximeter) and oxygen delivery device are attached in the operating theatre to the point at which they are removed.

Observations will be automatically uploaded onto the study computer at regular intervals (e.g. every 10 seconds for oxygen saturation).
Secondary outcome [1] 367194 0
Lowest recorded saturation using pulse oximetry
Timepoint [1] 367194 0
At any point during the bronchoscopy - from the point that the monitoring equipment (including pulse oximeter) and oxygen delivery device are attached in the operating theatre to the point at which they are removed.

Observations will be automatically uploaded onto the study computer at regular intervals (e.g. every 10 seconds for oxygen saturation).
Secondary outcome [2] 367221 0
Total duration of desaturation (SpO2 <94%)
Timepoint [2] 367221 0
At any point during the bronchoscopy - from the point that the monitoring equipment (including pulse oximeter) and oxygen delivery device are attached in the operating theatre to the point at which they are removed.

Observations will be automatically uploaded onto the study computer at regular intervals (e.g. every 10 seconds for oxygen saturation).
Secondary outcome [3] 367222 0
Total number of desaturations
Timepoint [3] 367222 0
At any point during the bronchoscopy - from the point that the monitoring equipment (including pulse oximeter) and oxygen delivery device are attached in the operating theatre to the point at which they are removed.

Observations will be automatically uploaded onto the study computer at regular intervals (e.g. every 10 seconds for oxygen saturation).
Secondary outcome [4] 367223 0
The proportion of participants experiencing a desaturation with an SpO2 <90%
Timepoint [4] 367223 0
At any point during the bronchoscopy - from the point that the monitoring equipment (including pulse oximeter) and oxygen delivery device are attached in the operating theatre to the point at which they are removed.

Observations will be automatically uploaded onto the study computer at regular intervals (every 10 seconds for oxygen saturation).
Secondary outcome [5] 367224 0
Number of airway interventions (the number of times the anaesthetist carries out an airway intervention (e.g. chin-lift or jaw-thrust). This will be counted and recorded by the Research Assistant during the procedure.
Timepoint [5] 367224 0
At any point during the bronchoscopy - from the point that the monitoring equipment and oxygen delivery device are attached in the operating theatre to the point at which they are removed.
Secondary outcome [6] 367226 0
The rate of pneumothoraces
Timepoint [6] 367226 0
Measured using post-procedural chest x-ray.
Secondary outcome [7] 367227 0
Grade of doctor conducting procedure when desaturation occurred (e.g. Registrar or Consultant)
Timepoint [7] 367227 0
At any point during the bronchoscopy
Secondary outcome [8] 367228 0
Bronchoscopist satisfaction – measured using a 5-point Likert scale
Timepoint [8] 367228 0
At the end of each bronchoscopy
Secondary outcome [9] 367391 0
Anaesthetists satisfaction – measured using a 5-point Likert scale
Timepoint [9] 367391 0
At the end of each bronchoscopy
Secondary outcome [10] 367392 0
Participant satisfaction – measured using a 5-point Likert scale
Timepoint [10] 367392 0
After the bronchoscopy, prior to discharge

Eligibility
Key inclusion criteria
Aged >=18 years old
Lung transplant patients
Undergoing transbronchial biopsy
English speaking and able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
The research assistant (person assessing the outcomes), bronchoscopist and participant will be blinded to the oxygen flow rated used. The Anaesthetist will not be blinded and will open the sealed envelope once the participant has been transferred into the anaesthetic bay.

The participants' oxygen saturation, blood pressure, heart rate and bispectral index recordings will be automatically and continuously downloaded from the monitoring equipment throughout the procedure.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 80 participants was calculated to detect a 33% difference in the proportion of participants experiencing a desaturation between the two arms of the trial assuming an alpha risk of 0.05 and a power of 0.8.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
50
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13218 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 25775 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 299143 0
Hospital
Name [1] 299143 0
St Vincent's Hospital Sydney
Country [1] 299143 0
Australia
Primary sponsor type
Individual
Name
Dr Charles Cartwright
Address
Department of Anaesthetics
390 Victoria Street
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 301853 0
Individual
Name [1] 301853 0
Dr Erez Ben-Menachemt
Address [1] 301853 0
Department of Anaesthetics
390 Victoria Street
Darlinghurst
NSW 2010
Country [1] 301853 0
Australia
Other collaborator category [1] 280562 0
Individual
Name [1] 280562 0
Dr Adrian Havryk
Address [1] 280562 0
Thoracic Medicine and Lung Transplantation
St Vincent’s Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country [1] 280562 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300073 0
St Vincent's Hospital Human Research Ethics Committee Ethics
Ethics committee address [1] 300073 0
Ethics committee country [1] 300073 0
Australia
Date submitted for ethics approval [1] 300073 0
08/02/2018
Approval date [1] 300073 0
21/03/2018
Ethics approval number [1] 300073 0
HREC/18/24/SVH/25

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82478 0
Dr Erez Ben-Menachem
Address 82478 0
Department of Anaesthetics
St Vincent’s Hospital Sydney
390 Victoria Street
Darlinghurst
NSW 2010
Country 82478 0
Australia
Phone 82478 0
+61283821111
Fax 82478 0
Email 82478 0
erezben@yahoo.com
Contact person for public queries
Name 82479 0
Charles Cartwright
Address 82479 0
Department of Anaesthetics
St Vincent’s Hospital Sydney
390 Victoria Street
Darlinghurst
NSW 2010
Country 82479 0
Australia
Phone 82479 0
+61404884012
Fax 82479 0
Email 82479 0
charles.cartwright@health.nsw.gov.au
Contact person for scientific queries
Name 82480 0
Charles Cartwright
Address 82480 0
Department of Anaesthetics
St Vincent’s Hospital Sydney
390 Victoria Street
Darlinghurst
NSW 2010
Country 82480 0
Australia
Phone 82480 0
+61283821111
Fax 82480 0
Email 82480 0
charles.cartwright@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseHigh-flow Nasal Oxygen Versus Standard Oxygen during Flexible Bronchoscopy in Lung Transplant Patients: A Randomized Controlled Trial.2020https://dx.doi.org/10.1097/LBR.0000000000000670
N.B. These documents automatically identified may not have been verified by the study sponsor.