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Trial registered on ANZCTR
Registration number
ACTRN12618001256268
Ethics application status
Approved
Date submitted
19/07/2018
Date registered
25/07/2018
Date last updated
2/10/2019
Date data sharing statement initially provided
2/10/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Airway oxygen concentration with high flow nasal oxygen
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Scientific title
Airway oxygen concentration in patients undergoing airway surgery with high flow nasal oxygen as the primary oxygenation technique
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Secondary ID [1]
295421
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypopharyngeal surgery
308660
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laryngotracheal surgery
308941
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Condition category
Condition code
Anaesthesiology
307599
307599
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0
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Anaesthetics
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Surgery
307840
307840
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The group being observed is patients undergoing elective airway surgery with apnoeic oxygenation and high flow nasal oxygen (HFNO) as their primary oxygenation technique.
The outcome or condition we are observing is the oxygen concentration in the airway, at the surgical site.
The exposure is that delivered oxygen concentration (FiO2) will be decreased from 100% to 30% for 60 seconds.
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Intervention code [1]
301727
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
306607
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Change in airway oxygen concentration.
This will be measured using a gas sampling line placed in the airway using surgical forceps. The line delivers respiratory gases to the AS5 gas analysis module fitted to GE Aisys anaesthetic machines.
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Assessment method [1]
306607
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Timepoint [1]
306607
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Airway oxygen concentration will be measured continuously for 60 seconds following the change in delivered oxygen concentration.
This will be carried out once with the tip of the gas sampling line at 1cm beyond the end of the rigid laryngoscope and once with the tip of the line 6cm beyond the end of the rigid laryngoscope.
Following these two measurements the sampling line will be removed and surgery will proceed.
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Primary outcome [2]
306608
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Rate of change of oxygen concentration (% per second).
As above, this will be measured with a gas sampling line in the airway.
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Assessment method [2]
306608
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Timepoint [2]
306608
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As above, airway O2 concentration will be measured continuously for 60seconds. This will provide both an overall rate of change (average over 1 minute) and a profile of the change ie exponential vs linear.
This will be carried out with the gas sampling line at 1cm and 6cm beyond the rigid laryngoscope.
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Secondary outcome [1]
348990
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Total anaesthetic apnoeic time (minutes).
This will be recorded by stopwatch from time of rocuronium administration to whichever is sooner of 1. time first spontaneous breath is taken or 2. first positive pressure ventilation breath is administered.
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Assessment method [1]
348990
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Timepoint [1]
348990
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The secondary outcome is a timepoint and will be measured in minutes + seconds.
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Secondary outcome [2]
348991
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Lowest recorded O2 saturation.
O2 saturations are measured by the GE Datex monitors in real time. Lowest O2 saturation will be recorded by the anaesthetist during the anaesthetic and will be corroborated by retrospective interrogation of monitor data.
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Assessment method [2]
348991
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Timepoint [2]
348991
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Lowest recorded O2 saturation during the apnoeic period.
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Secondary outcome [3]
348992
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Change of anaesthetic technique.
If prior to completion of surgery positive pressure ventilation is undertaken at the discretion of the anaesthetist, including
- bag mask ventilation
- jet ventilation
- placement of an endotracheal tube
- placement of an laryngeal mask airway
this will be considered a change of anaesthetic technique.
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Assessment method [3]
348992
0
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Timepoint [3]
348992
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For the duration of the surgical procedure
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Eligibility
Key inclusion criteria
Patients undergoing elective hypopharyngeal or laryngotracheal surgery where apnoeic oxygenation with High Flow Nasal Oxygen (HFNO) is the chosen anaesthetic technique
Patients aged 18-75 years
Patients deemed ASA 1-3
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Unable to give valid consent
BMI >35
Not otherwise suitable for HFNO technique as deemed by anaesthetist
ASA 4-5
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Data will be presented as mean +/- standard deviation and p values will be calculated using the unpaired student's t-test
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
24/09/2018
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Actual
3/07/2019
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Date of last participant enrolment
Anticipated
30/11/2019
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Actual
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Date of last data collection
Anticipated
30/11/2019
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Actual
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Sample size
Target
10
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Accrual to date
6
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Final
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Recruitment outside Australia
Country [1]
10616
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New Zealand
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State/province [1]
10616
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Christchurch, canterbury
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Funding & Sponsors
Funding source category [1]
300007
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Hospital
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Name [1]
300007
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Christchurch Public Hospital
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Address [1]
300007
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Department of Anaesthesia
Christchurch public hospital
2 Riccarton ave
Christchurch 8011
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Country [1]
300007
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New Zealand
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Primary sponsor type
Hospital
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Name
Christchurch public hospital
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Address
Department of Anaesthesia
2 Riccarton AVe
Christchurch 8011
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Country
New Zealand
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Secondary sponsor category [1]
299393
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None
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Name [1]
299393
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n/a
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Address [1]
299393
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n/a
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Country [1]
299393
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300861
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Health and disability ethics committee NZ
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Ethics committee address [1]
300861
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Ministry of Health
Health and Disability Ethics Committee
PO box 5013
Wellington 6140
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Ethics committee country [1]
300861
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New Zealand
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Date submitted for ethics approval [1]
300861
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15/08/2019
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Approval date [1]
300861
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22/02/2019
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Ethics approval number [1]
300861
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18/NTA/196
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Summary
Brief summary
This is an observational study looking at patients undergoing airway surgery where High Flow Nasal Oxygen (HFNO) is used for patient oxygenation during a period of sustained apnoea.
The study aims to characterise the change in oxygen (O2) concentration in the airway when O2 delivered by HFNO is decreased from 100% down to 30%
This will enable us to objectively quantify oxygen levels at the surgical site when HFNO is being used to provide sustained apnoeic oxygenation
As such it is anticipated that the study will represent a valuable contribution to patient safety by informing strategies that ensure safe and optimal surgical conditions during airway surgery in the presence of an ignition source.
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Trial website
n/a
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Trial related presentations / publications
nil as yet
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Public notes
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Attachments [1]
2898
2898
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0
/AnzctrAttachments/375503-HFNO protocol ANZCTR.pdf
(Protocol)
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Contacts
Principal investigator
Name
85070
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Dr Nick Abbott
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Address
85070
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Department of Anaesthesia
Christchurch Public hospital
2 Riccarton ave
Christchurch 8011
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Country
85070
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New Zealand
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Phone
85070
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+6421373527
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Fax
85070
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Email
85070
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[email protected]
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Contact person for public queries
Name
85071
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Dr Nick Abbott
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Address
85071
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Department of Anaesthesia
Christchurch Public hospital
2 Riccarton ave
Christchurch 8011
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Country
85071
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New Zealand
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Phone
85071
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+6421373527
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Fax
85071
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Email
85071
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[email protected]
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Contact person for scientific queries
Name
85072
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Dr Pippa Jerram
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Address
85072
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Department of Anaesthesia
Christchurch public hospital
2 Riccarton ave
Christchurch 8011
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Country
85072
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New Zealand
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Phone
85072
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+6421747710
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Fax
85072
0
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Email
85072
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
their is no provision in the consent for participation in this study, for individual data to be shared.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5127
Informed consent form
375503-(Uploaded-28-09-2019-13-00-17)-Study-related document.pdf
5128
Ethical approval
375503-(Uploaded-28-09-2019-13-01-34)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF