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Trial registered on ANZCTR
Registration number
ACTRN12624000766516
Ethics application status
Approved
Date submitted
27/05/2024
Date registered
24/06/2024
Date last updated
24/06/2024
Date data sharing statement initially provided
24/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
An investigation of Gas Flows during Preoxygenation with Nasal High Flow in volunteers
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Scientific title
An investigation of Gas Flows during Preoxygenation with Nasal High Flow in volunteers
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Secondary ID [1]
312224
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None
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Universal Trial Number (UTN)
U1111-1308-5523
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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:
Preoxygenation
333921
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Condition category
Condition code
Anaesthesiology
330591
330591
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0
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Anaesthetics
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Respiratory
330692
330692
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0
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Normal development and function of the respiratory system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Healthy volunteer participants will be reclined on a hospital bed at 20 degrees in a laboratory setting. Two researchers will be present; one to operate the equipment and the other to monitor the participant.
Flow, generated by a computer-controlled flow source (custom, Fisher&Paykel Healthcare, New Zealand) will pass through a humidifier (950, Fisher & Paykel Healthcare, New Zealand) before being administered to the participant through a nasal interface, either a high flow interface (AA001, Fisher & Paykel Healthcare, New Zealand) or a low flow cannula (Hudson standard nasal tip, Teleflex, Morrisville, USA).
Tolerability Assessment:
An initial test will be performed to check the participant's tolerance to flow and mouth open/closed combinations by increasing flow (10, 25, 40, 55, 70 L/min) until either the flow reaches 70 L/min or the participant indicates it is not tolerable.
Measurements:
The participant will be fitted with a modified CPAP mask (FitLife Total, Phillips, Netherlands). A mouthpiece extends from the participant’s mouth through the body of the mask to atmosphere. This mouthpiece is modified from a commercially available spirometry mouthpiece (EasyOne, ndd Medizintechnik AG, Switzerland). An additional port provides a path for gas from inside the mask to atmosphere. It should be noted that there is always a gas path to atmosphere to ensure the participant can breathe.
Three flow meters (SFM3200-AW, Sensirion, Switzerland) are in the system. These flow meters measure the flow rate:
1. from the flow source,
2. entering or exiting the mouth through the mouthpiece and
3. entering/exiting the mask body through the port through the mask body.
The flow meters are sampled, and the results written to a file on the PC.
The flow-weighted FiO2 (the primary endpoint) can be calculated from these three flow readings
The following flow, cannula and mouth open/closed combinations will be administered for 120s per combination however the first 20s of data will be discarded as this has been set aside to allow the next set up to be established (i.e the 'washout' period of 20s is built into the 120s period and only the last 100s of data will be used for each combination).
o 10 L.min-1 through low flow cannula (Hudson standard nasal tip, Teleflex, Morrisville, USA )
o Flows through High Flow Nasal Oxygen (HFNO) cannula (Optiflow, Fisher & Paykel Healthcare, Auckland, New Zealand)
of :
o 10, 25, 40, 55, 70 L.min-1
with:
1. Mouth open
2. Mouth closed
This is a cross over study and each participant will receive all of the combinations (subject to finding these combinations tolerable).
We estimate the total time for a participant will be approximately 60 minutes.
The concentration of carbon dioxide in the mask body and the participant's oxygen saturation will be monitored for safety.
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Intervention code [1]
328676
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Prevention
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Intervention code [2]
328754
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Treatment: Devices
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Comparator / control treatment
10 L.min-1 through low flow cannula, with mouth open (Standard care)
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Control group
Active
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Outcomes
Primary outcome [1]
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Flow-weighted mean fraction of inspired oxygen over 100s at flows of:
a) 10 L/min through low flow cannula (Hudson standard nasal tip, Teleflex, Morrisville, USA )
b) Flows through HFNO cannula (Optiflow, Fisher & Paykel Healthcare, Auckland, New Zealand) of :
10, 25, 40, 55, 70 L./min
with:
1. Mouth open
2. Mouth closed (achieved by placing a cap over the external exit of the mouth piece)
This endpoint will be assessed independently for each combination
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Assessment method [1]
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Participants will wear a sealed mask which:
1. allows the delivery of low or high flow oxygen through nasal prongs.
2. incorporates a mouth piece that connects the patient's mouth to ambient through a flow meter. This measures a combination of the portion of the participant's expired breath and the portion of the flow from the nasal prongs which exits via the mouth and
3. incorporates a second flow meter between the body of the mask and the ambient environment which measures the combination of the expired patient flow through the nose and the flow from the (unsealed) nasal prongs that exits via the space between the prongs and the nares
A third flow meter measures the incoming gas flow.
From these three flow measurements a calculation can be performed to find the FiO2 the participant inspires on each breath. This is averaged over 100s to find the primary endpoint.
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Timepoint [1]
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Assessed continuously for 100 seconds during each intervention test
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Secondary outcome [1]
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• Flow rates through the mouth and nose originating from:
o The participant
o the HFNO system
i.e. this outcome assesses where the flow from the HFNO system goes and where the flow to/from the patient goes. It is considered one outcome.
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Assessment method [1]
435529
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Participants will wear a sealed mask which:
1. allows the delivery of low or high flow oxygen through nasal prongs.
2. incorporates a mouth piece that connects the patient's mouth to ambient through a flow meter. This measures a combination of the portion of the participant's expired breath and the portion of the flow from the nasal prongs which exits via the mouth and
3. incorporates a second flow meter between the body of the mask and the ambient environment which measures the combination of the expired patient flow through the nose and the flow from the (unsealed) nasal prongs that exits via the space between the prongs and the nares
A third flow meter measures the incoming gas flow.
From these three flow measurements a calculation can be performed to find the flow rates from the nose and mouth from the participant and the high flow system.
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Timepoint [1]
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Assessed continuously for 100 seconds during each intervention test and then calculated
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Secondary outcome [2]
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Continuous estimated FiO2
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Assessment method [2]
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Participants will wear a sealed mask which:
1. allows the delivery of low or high flow oxygen through nasal prongs.
2. incorporates a mouth piece that connects the patient's mouth to ambient through a flow meter. This measures a combination of the portion of the participant's expired breath and the portion of the flow from the nasal prongs which exits via the mouth and
3. incorporates a second flow meter between the body of the mask and the ambient environment which measures the combination of the expired patient flow through the nose and the flow from the (unsealed) nasal prongs that exits via the space between the prongs and the nares
A third flow meter measures the incoming gas flow.
From these three flow measurements a calculation can be performed to find the FiO2 the participant inspires at each point over 100s. Note: This measurement is only valid during inspiration.
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Timepoint [2]
435530
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Assessed continuously for 100 seconds during each intervention test
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Secondary outcome [3]
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Peak inspiratory demand through the mouth and / or nose
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Assessment method [3]
435531
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Participants will wear a sealed mask which:
1. allows the delivery of low or high flow oxygen through nasal prongs.
2. incorporates a mouth piece that connects the patient's mouth to ambient through a flow meter. This measures a combination of the portion of the participant's expired breath and the portion of the flow from the nasal prongs which exits via the mouth and
3. incorporates a second flow meter between the body of the mask and the ambient environment which measures the combination of the expired patient flow through the nose and the flow from the (unsealed) nasal prongs that exits via the space between the prongs and the nares
A third flow meter measures the incoming gas flow.
From these three flow measurements a calculation can be performed to find the peak inspiratory demand for each breath during the 100s measurement time.
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Timepoint [3]
435531
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Assessed continuously for 100 seconds during each intervention test
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Secondary outcome [4]
435532
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Respiratory rate
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Assessment method [4]
435532
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Participants will wear a sealed mask which:
1. allows the delivery of low or high flow oxygen through nasal prongs.
2. incorporates a mouth piece that connects the patient's mouth to ambient through a flow meter. This measures a combination of the portion of the participant's expired breath and the portion of the flow from the nasal prongs which exits via the mouth and
3. incorporates a second flow meter between the body of the mask and the ambient environment which measures the combination of the expired patient flow through the nose and the flow from the (unsealed) nasal prongs that exits via the space between the prongs and the nares
A third flow meter measures the incoming gas flow.
From these three flow measurements a calculation can be performed to find the average respiratory rate during the 100s measurement time.
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Timepoint [4]
435532
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Assessed continuously for 100 seconds during each intervention test
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Secondary outcome [5]
435533
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Tidal volume
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Assessment method [5]
435533
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Participants will wear a sealed mask which:
1. allows the delivery of low or high flow oxygen through nasal prongs.
2. incorporates a mouth piece that connects the patient's mouth to ambient through a flow meter. This measures a combination of the portion of the participant's expired breath and the portion of the flow from the nasal prongs which exits via the mouth and
3. incorporates a second flow meter between the body of the mask and the ambient environment which measures the combination of the expired patient flow through the nose and the flow from the (unsealed) nasal prongs that exits via the space between the prongs and the nares
A third flow meter measures the incoming gas flow.
From these three flow measurements a calculation can be performed to find the tidal volume for each breath during the 100s measurement time.
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Timepoint [5]
435533
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Assessed continuously for 100 seconds during each intervention test
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Secondary outcome [6]
435534
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Lung volume change
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Assessment method [6]
435534
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Participants will wear a sealed mask which:
1. allows the delivery of low or high flow oxygen through nasal prongs.
2. incorporates a mouth piece that connects the patient's mouth to ambient through a flow meter. This measures a combination of the portion of the participant's expired breath and the portion of the flow from the nasal prongs which exits via the mouth and
3. incorporates a second flow meter between the body of the mask and the ambient environment which measures the combination of the expired patient flow through the nose and the flow from the (unsealed) nasal prongs that exits via the space between the prongs and the nares
A third flow meter measures the incoming gas flow.
From these three flow measurements over time a calculation can be performed to find the change in lung volume (the difference between gas inspired and expired on complete breaths) during the 100s measurement time.
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Timepoint [6]
435534
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Assessed continuously for 100 seconds during each intervention test
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Secondary outcome [7]
435535
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Tolerability (binary) to different flow combinations (flow rate and mouth open/closed)
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Assessment method [7]
435535
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Participant's will be asked verbally if each combination is tolerable by a researcher who will then note it on the case report form.
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Timepoint [7]
435535
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We will assess tolerability to each flow with and without mouth closed for 30s per combination before fitting the measurement mask. Only tolerated flows will be assessed with the measurement mask. This is for participant comfort.
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Secondary outcome [8]
435537
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Compliance with each flow condition during measurement part of study
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Assessment method [8]
435537
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Investigator observation
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Timepoint [8]
435537
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Assessed continuously for 100 seconds during each intervention test
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Eligibility
Key inclusion criteria
Volunteer participants 16 years and over
capable of informed consent
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Minimum age
16
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
HFNO contraindicated as per manufacturer’s instructions (AA001, Fisher & Paykel Healthcare, Auckland, New Zealand
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/07/2024
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Actual
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Date of last participant enrolment
Anticipated
27/06/2025
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Actual
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Date of last data collection
Anticipated
27/06/2025
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Actual
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26337
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New Zealand
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State/province [1]
26337
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Auckland
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Funding & Sponsors
Funding source category [1]
316603
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University
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Name [1]
316603
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University of Auckland
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Address [1]
316603
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Country [1]
316603
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
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Country
New Zealand
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Secondary sponsor category [1]
318785
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None
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Name [1]
318785
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Address [1]
318785
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Country [1]
318785
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315387
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
315387
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https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
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Ethics committee country [1]
315387
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New Zealand
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Date submitted for ethics approval [1]
315387
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Approval date [1]
315387
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18/09/2023
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Ethics approval number [1]
315387
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2023 EXP 18477
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Summary
Brief summary
This study is hypothesis generating and intended to characterise key variables during pre oxygenation with HFNO. The primary endpoint will be the flow-weighted mean fraction of inspired oxygen (FiO2) over 100s at flows of 10, 25, 40, 55, and 70 L.min-1 with i) the mouth open and ii) the mouth closed. To ensure these flows are tolerable to the participant, each combination will first be administered to the participant without the measurement apparatus in place. Only those combinations that are tolerable will then be administered in the main part of the study. Tolerance to flow combinations will be reported as a secondary outcome. Measurements at 10 L.min-1 will be performed with both HFNO prongs and standard low flow prongs, as the latter are commonly used in clinical practice.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Matthew Payton
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Address
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Daniell Building, Fisher & Paykel Healthcare, 15 Maurice Paykel Place, Auckland 2013
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Country
134542
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New Zealand
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Phone
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+64 21 774 887
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Fax
134542
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Email
134542
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[email protected]
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Contact person for public queries
Name
134543
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Matthew Payton
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Address
134543
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Daniell Building, Fisher & Paykel Healthcare, 15 Maurice Paykel Place, Auckland 2013
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Country
134543
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New Zealand
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Phone
134543
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+64 21 774 887
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Fax
134543
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Email
134543
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[email protected]
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Contact person for scientific queries
Name
134544
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Matthew Payton
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Address
134544
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Daniell Building, Fisher & Paykel Healthcare, 15 Maurice Paykel Place, Auckland 2013
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Country
134544
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New Zealand
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Phone
134544
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+64 21 774 887
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Fax
134544
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Email
134544
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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
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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
No additional documents have been identified.
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