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Trial registered on ANZCTR


Registration number
ACTRN12615000206527
Ethics application status
Approved
Date submitted
16/02/2015
Date registered
3/03/2015
Date last updated
24/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
High Flow Nasal Oxygenation for General Thoracic Patients during Diagnostic Bronchoscopy. Comparison of conventional methods of respiratory support during bronchoscopy vs. High Flow Nasal Cannula.
Scientific title
General thoracic patients undergoing diagnostic bronchoscopy receiving High Flow oxygen therapy for respiratory support vs. conventional low flow oxygen therapy for respiratory support to reduce recovery/hospital time and maintain lung volumes
Secondary ID [1] 286168 0
None
Universal Trial Number (UTN)
U1111-1167-2001
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory support for general thoracic patients undergoing Bronchoscopy 294183 0
Condition category
Condition code
Respiratory 294506 294506 0 0
Other respiratory disorders / diseases
Anaesthesiology 294507 294507 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nasal high flow oxygen therapy has been widely investigated in many areas of in-hospital patient care. It can deliver up to 60L/min of humidified air and oxygen. Documented mechanisms of action for high flow include dead space clearance and washout, splinting of the upper airway and maintaining pulmonary conductance and compliance. Participants undergoing diagnostic bronchoscopy will be deemed 'high' or 'low' risk by treating anaesthetist, as per standard practice at this institution.

'Low' risk participants will receive light sedation and local anaesthetic for their bronchoscopy. Participants in this group will be randomised to receive either High Flow nasal cannula oxygen therapy at 60L/min or standard practice low flow oxygen therapy via nasal cannula or bite block (decision on nasal cannula vs. bite block will be at the discretion of the treating physician) for the duration of their bronchoscopy procedure and in recovery. Observational 'High' risk participants will receive general anaesthesia and a dedicated airway (LMA). Standard oxygen therapy will be administered during recovery. Study period will be approximately two hours for procedure and recovery time. Time will vary depending on bronchoscopy findings.

Continuous haemodynamics, pharyngeal pressures and electrical impedance tomography, specifically end expiratory lung volumes, will be monitored. Additionally, time in and out of recovery will be documented as well as patient/staff satisfaction survey recorded.
Intervention code [1] 291173 0
Treatment: Devices
Comparator / control treatment
Comparator 'Low' risk participants will receive light sedation and local anaesthetic for their bronchoscopy. Participants in this group will receive standard practice low flow oxygen therapy at 6L/min via nasal cannula or bite block for the duration of their procedure and recovery. Decision on nasal cannula vs. bite block will be at the discretion of the treating physician. Observational 'High' risk participants will receive general anaesthesia and a dedicated airway (LMA). Standard oxygen therapy will be administered during recovery. Study period will be approximately two hours for procedure and recovery time. Time will vary depending on bronchoscopy findings.
Control group
Active

Outcomes
Primary outcome [1] 294310 0
Change in end-expiratory lung volume from patient's baseline using electrical impedance tomography.
Timepoint [1] 294310 0
Pre-procedure, intra-procedure (on commencement of bronchoscopy and on commencement of bronchoalveolar lavage), immediately post procedure, and 30 minutes post-procedure.
Secondary outcome [1] 313006 0
Change is SpO2/FiO2 ratio from baseline
Timepoint [1] 313006 0
Change is SpO2/FiO2 ratio from baseline will be calculated by comparing the patient's baseline ratio to ratios Immediately pre-bronchoscope initiation (after sedative administration), at time of bronchoscopy initiation (after the bronchoscope is passed through the vocal cords), during bronchoalveolar lavage (during lavage saline administration and suction), immediately post-bronchoscopy (immediately after bronchoscope is withdrawn), at the beginning of the post-operative period (immediately after patient is moved to recovery), and at 30 minutes post-procedure (after the patient has been in recovery for 30 minutes).
Secondary outcome [2] 313007 0
Change in CO2 from baseline using a transcutaneous carbon dioxide monitor.
Timepoint [2] 313007 0
CO2 levels will be taken at the following timepoints:
1) pre-procedure (baseline), 2) Immediately pre-bronchoscope initiation (after sedative administration), 3) At time of bronchoscopy initiation (after the bronchoscope is passed through the vocal cords), 4) During bronchoalveolar lavage (during lavage saline administration and suction), 5) Immediately post-bronchoscopy (immediately after bronchoscope is withdrawn), 6) Beginning of post-operative period (immediately after patient is moved to recovery), 7) At 30 minutes post-procedure (after the patient has been in recovery for 30 minutes).
Secondary outcome [3] 313008 0
Lowest SpO2 during the procedure via transcutaneous oximetry monitoring.
Timepoint [3] 313008 0
Continuously during the bronchoscopy procedure.
Secondary outcome [4] 327327 0
Patient dyspnoea and comfort via a 10-point, visual analogue scale.
Timepoint [4] 327327 0
Once before the procedure (using a 10 point analogue score), and once after the procedure (using a 10 point analogue score).
Secondary outcome [5] 327328 0
Bronchoscopist and bronchoscopy staff satisfaction using a 7-point analogue scale after the conclusion of the procedure.
Timepoint [5] 327328 0
Post-procedure.
Secondary outcome [6] 327329 0
Economic Evaluation through the assessment of the cost of human and material resources.
Timepoint [6] 327329 0
Entire patient admission.

Eligibility
Key inclusion criteria
1. Eighteen (18) years +
2. Routine bronchoscopy in general thoracic patients
3. Able to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Unable to give informed consent
2) Transbronchial biopsy
3) Markedly deviated septum
4) Sinus problems or nasal trauma
5) Aspiration risk (pre-existing gastroparesis or known severe GORD)
6) Chest circumfrence larger than the Electrical Impedance Tomography belt.
7) Reduced level of consciousness
8) Pneumothorax (or within the last 2 weeks)
9) Not suitable for high flow nasal cannulae or pharyngeal catheter due to recent surgery and/or epistaxis.

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)
Participants will be approached during outpatient appointment prior to the bronchoscopy and consent will be obtained. Allocation for 'low' risk participant group will be performed by external research personnel separate to the study, Allocation will be concealed until just prior to the procedure by sealed, consecutively numbered, opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin-tossing and dice-rolling.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As there is no existing data regarding the primary outcome (EELV loss during bronchoscopy), we have based the sample size calculation on our previous study investigating lung volume loss during suctioning. For Part A, if we assume a power of 90% and a two-sided significance of 5%, we will require 17 patients in each arm to detect a 25% difference in EELV between groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2016
Actual
6/04/2016
Date of last participant enrolment
Anticipated
6/04/2017
Actual
10/03/2017
Date of last data collection
Anticipated
Actual
10/03/2017
Sample size
Target
34
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3453 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 9224 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 290755 0
Other Collaborative groups
Name [1] 290755 0
Critical Care Research Group
Country [1] 290755 0
Australia
Funding source category [2] 290861 0
Commercial sector/Industry
Name [2] 290861 0
Fisher & Paykel Healthcare
Country [2] 290861 0
New Zealand
Primary sponsor type
Individual
Name
Professor John Fraser
Address
Adult Intensive Care Service/Critical Care Research Group
The Prince Charles Hospital
Rode Road
Chermside, Brisbane
Queensland 4032
Country
Australia
Secondary sponsor category [1] 289443 0
Individual
Name [1] 289443 0
Amanda Corley
Address [1] 289443 0
Critical Care Research Group
The Prince Charles Hospital
Rode Road
Chermside, Brisbane
Queensland 4032
Country [1] 289443 0
Australia
Other collaborator category [1] 278352 0
Individual
Name [1] 278352 0
Associate Professor Peter Hopkins
Address [1] 278352 0
Queensland Centre for Pulmonary Transplantation and Vascular Disease
The Prince Charles Hospital
Rode Road
Chermside, Brisbane
Queensland 4032
Country [1] 278352 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295367 0
Metro North Hospital and Health Service - The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 295367 0
Ethics committee country [1] 295367 0
Australia
Date submitted for ethics approval [1] 295367 0
28/10/2014
Approval date [1] 295367 0
04/11/2014
Ethics approval number [1] 295367 0
HREC/14/QPCH/198

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

Contacts
Principal investigator
Name 54890 0
Prof John Fraser
Address 54890 0
Critical Care Research Group
Adult Intensive Care Service
The Prince Charles Hospital
Rode Road
Chermside, Brisbane
Queensland 4032
Country 54890 0
Australia
Phone 54890 0
+61 407 128 039
Fax 54890 0
Email 54890 0
John.Fraser@health.qld.gov.au
Contact person for public queries
Name 54891 0
Amanda Corley
Address 54891 0
Critical Care Research Group
Adult Intensive Care Service
The Prince Charles Hospital
Rode Road
Chermside, Brisbane
Queensland 4032
Country 54891 0
Australia
Phone 54891 0
+61 7 31395772
Fax 54891 0
Email 54891 0
amanda.corley@health.qld.gov.au
Contact person for scientific queries
Name 54892 0
Amanda Corley
Address 54892 0
Critical Care Research Group
Adult Intensive Care Service
The Prince Charles Hospital
Rode Road
Chermside, Brisbane
Queensland 4032
Country 54892 0
Australia
Phone 54892 0
+61 7 31395772
Fax 54892 0
Email 54892 0
amanda.corley@health.qld.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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