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Trial registered on ANZCTR


Registration number
ACTRN12618000458235
Ethics application status
Approved
Date submitted
19/03/2018
Date registered
29/03/2018
Date last updated
5/06/2019
Date data sharing statement initially provided
5/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of a single-prong nasal cannula to deliver Nasal High Flow therapy in healthy volunteers
Scientific title
Feasibility of a single-prong nasal cannula to deliver Nasal High Flow therapy in healthy volunteers
Secondary ID [1] 294021 0
CIA-226
Universal Trial Number (UTN)
U1111-1209-2368
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory distress 306545 0
Respiratory failure 306546 0
Chronic obstructive pulmonary disease 306547 0
Condition category
Condition code
Respiratory 306024 306024 0 0
Chronic obstructive pulmonary disease
Respiratory 306273 306273 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Optiflow Uno - a single prong nasal interface to deliver Nasal High Flow

The participant will spend two nights in the Sleep Lab. On one night the participant will receive the Optiflow Uno (intervention) and on the other night the Optiflow+ (control); the order that each device is received will be randomized.

The AIRVO 2 will be used to generate the high flows and to heat and humidify the respiratory gas. The flows delivered via the Optiflow Uno will range between 0 to 30 L/min of heated and humidified room air. There are two parts to the study; 1) changes in breathing in response to Nasal High Flow therapy during both wakefulness and sleep and 2) perception of the Nasal High Flow therapy as delivered by the device.

Part 1: Breathing will be measured using respiratory inductance plethysmography during periods of receiving no therapy (baseline) and Nasal High Flow therapy (intervention) when awake and asleep. During sleep, breathing responses to Nasal High Flow therapy will be obtained during non-REM sleep. During part 1, breathing will be measured during different flow rates of Nasal High Flow (0 to 30 L/min); each flow rate will be applied for a maximum of 30 minutes at a time.

Part 2: Once breathing responses are obtained, the flow rate of the Nasal High Flow will be set at the level that the subject went to sleep with, and is comfortable with, for the rest of the night. The subject is free to wake at any time and to remove the nasal interface at any time. At the time of waking the subject will be asked to fill in questionnaires and answer questions relating to the experience of the nasal interface.

The study will be conducted in the Fisher and Paykel Sleep Lab located in Auckland, NZ and will be performed by Fisher and Paykel Healthcare Scientists
Intervention code [1] 300294 0
Treatment: Devices
Comparator / control treatment
Optiflow+ - standard two-prong nasal interface to deliver Nasal High Flow

The same protocol will be followed as per the intervention (Optiflow Uno) but the Optiflow+ nasal interface will be applied.

The AIRVO 2 will be used to generate the high flows and to heat and humidify the respiratory gas. The flows delivered via the Optiflow Uno will range between 0 to 45 L/min of heated and humidified room air. There are two parts to the study; 1) changes in breathing in response to Nasal High Flow therapy during both wakefulness and sleep and 2) perception of the Nasal High Flow therapy as delivered by the device.

Part 1: Breathing will be measured using respiratory inductance plethysmography during periods of receiving no therapy (baseline) and Nasal High Flow therapy (intervention) when awake and asleep. During sleep, breathing responses to Nasal High Flow therapy will be obtained during non-REM sleep. During part 1, breathing will be measured during different flow rates of Nasal High Flow (0 to 30 L/min); each flow rate will be applied for a maximum of 30 minutes at a time.

Part 2: Once breathing responses are obtained, the flow rate of the Nasal High Flow will be set at the level that the subject went to sleep with, and is comfortable with, for the rest of the night. The subject is free to wake at any time and to remove the nasal interface at any time. At the time of waking the subject will be asked to fill in questionnaires and answer questions relating to the experience of the nasal interface.

The study will be conducted in the Fisher and Paykel Sleep Lab located in Auckland, NZ and will be performed by Fisher and Paykel Healthcare Scientists.
Control group
Active

Outcomes
Primary outcome [1] 304761 0
Minute ventilation as measured by respiratory inductance plethysmography
Timepoint [1] 304761 0
1: During wakefulness, before and 20 minutes after initiation of therapy
2: During NREM sleep, before and 20 minutes after initiation of therapy
Secondary outcome [1] 343026 0
Tidal volume as measured by respiratory inductance plethysmography
Timepoint [1] 343026 0
1: During wakefulness, before and 20 minutes after initiation of therapy
2: During NREM sleep, before and 20 minutes after initiation of therapy
Secondary outcome [2] 343027 0
Respiratory rate as measured by respiratory inductance plethysmography
Timepoint [2] 343027 0
1: During wakefulness, before and 20 minutes after initiation of therapy
2: During NREM sleep, before and 20 minutes after initiation of therapy
Secondary outcome [3] 343031 0
Comfort of interface as measured by questionnaire. The questionnaire is designed specifically for the study.
Timepoint [3] 343031 0
The questionnaire will be provided at the time of waking
Secondary outcome [4] 343033 0
Stability of the flows being delivered by the AIRVO2 as measured using machine analytics
Timepoint [4] 343033 0
Measured during the entire time that the interface is being worn
Secondary outcome [5] 343034 0
Noise level of the interface as measured by questionnaire. The questionnaire is designed specifically for the study.
Timepoint [5] 343034 0
The questionnaire will be provided at the time of waking
Secondary outcome [6] 343035 0
Expiratory time as measured by respiratory inductance plethysmography
Timepoint [6] 343035 0
1: During wakefulness, before and 20 minutes after initiation of therapy
2: During NREM sleep, before and 20 minutes after initiation of therapy
Secondary outcome [7] 344681 0
Inspiratory time as measured by respiratory inductance plethysmography
Timepoint [7] 344681 0
1: During wakefulness, before and 20 minutes after initiation of therapy
2: During NREM sleep, before and 20 minutes after initiation of therapy

Eligibility
Key inclusion criteria
1. Between 18 and 40 years of age
2. Male
3. No diagnosis of sleep or respiratory conditions
4. Successfully passed a medical check-up for pre-existing sleep or respiratory conditions
5. Low score on the ‘Stop-Bang Sleep Apnoea Questionnaire’
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
1) Under 18 years of age
2) Female
3) Existence of sleep or respiratory conditions such as sleep apnea and asthma or allergies

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Initial treatment to be decided by coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
10 healthy volunteers will be selected as participants for this investigation. According to the FDA guidance on Human Factors Engineering, a sample size of 10 will allow a mean of 94.69% of usability problems to be identified (minimum 82%). This is deemed to be appropriate for this investigation.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/04/2018
Actual
5/04/2018
Date of last participant enrolment
Anticipated
1/04/2019
Actual
10/05/2018
Date of last data collection
Anticipated
1/04/2019
Actual
10/05/2018
Sample size
Target
10
Accrual to date
Final
5
Recruitment outside Australia
Country [1] 9580 0
New Zealand
State/province [1] 9580 0

Funding & Sponsors
Funding source category [1] 298642 0
Commercial sector/Industry
Name [1] 298642 0
Fisher and Paykel Healthcare
Country [1] 298642 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
O’hare Building
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country
New Zealand
Secondary sponsor category [1] 297819 0
None
Name [1] 297819 0
Address [1] 297819 0
Country [1] 297819 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299602 0
Massey University Human Ethics Committee
Ethics committee address [1] 299602 0
Ethics committee country [1] 299602 0
New Zealand
Date submitted for ethics approval [1] 299602 0
03/08/2017
Approval date [1] 299602 0
15/08/2017
Ethics approval number [1] 299602 0
SOA 16/80 - Nasal high flow during wake and sleep: Effects of Nasal interface on ventilation

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

Contacts
Principal investigator
Name 80990 0
Dr Toby Mundel
Address 80990 0
School of Sport, Exercise and Nutrition
Massey University Manawatu (Turitea)
Tennent Drive
Palmerston North 4474
New Zealand
Country 80990 0
New Zealand
Phone 80990 0
+64 6 356 9099 ext. 84538
Fax 80990 0
Email 80990 0
t.mundel@massey.ac.nz
Contact person for public queries
Name 80991 0
Toby Mundel
Address 80991 0
School of Sport, Exercise and Nutrition
Massey University Manawatu (Turitea)
Tennent Drive
Palmerston North 4474
New Zealand
Country 80991 0
New Zealand
Phone 80991 0
+64 6 356 9099 ext. 84538
Fax 80991 0
Email 80991 0
t.mundel@massey.ac.nz
Contact person for scientific queries
Name 80992 0
Toby Mundel
Address 80992 0
School of Sport, Exercise and Nutrition
Massey University Manawatu (Turitea)
Tennent Drive
Palmerston North 4474
New Zealand
Country 80992 0
New Zealand
Phone 80992 0
+64 6 356 9099 ext. 84538
Fax 80992 0
Email 80992 0
t.mundel@massey.ac.nz

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
No additional documents have been identified.