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Trial registered on ANZCTR


Registration number
ACTRN12619000831189
Ethics application status
Approved
Date submitted
30/05/2019
Date registered
7/06/2019
Date last updated
13/07/2021
Date data sharing statement initially provided
7/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Nasal High Flow via a Single, Sealed Nostril in Patients with Respiratory Failure
Scientific title
Respiratory Rate in patients with Respiratory Failure in response to Nasal High Flow Therapy delivered via a single sealed nostril
Secondary ID [1] 298361 0
CIA-248
Universal Trial Number (UTN)
U1111-1218-2041
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Failure 313020 0
Condition category
Condition code
Respiratory 311525 311525 0 0
Chronic obstructive pulmonary disease
Respiratory 311526 311526 0 0
Other respiratory disorders / diseases
Respiratory 311527 311527 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study purpose is to test the delivery of Nasal High Flow (NHF) therapy via a single, sealed nostril in adult patients with respiratory failure who are receiving NHF therapy as their standard care in the intensive care unit (ICU) or high dependency unit (HDU). The therapy will be applied by trained hospital staff.

The NHF therapy will be delivered via the single, sealed nostril for up-to one-hour in patients who were already receiving NHF therapy via a two-prong interface (i.e. comparator) as their standard care. Before and after using the investigative interface the participant will receive the NHF therapy via the comparator interface. Despite a brief transition time during the exchange of interfaces, there will be no period of time when the patient is not receiving NHF therapy during the study. The primary end-point will be ventilation parameters at ne-hour following the application of the investigative interface for one-hour. The study is a prospective, cross-over design.

The study will last for two and a half (2.5) hours. The settings of the NHF while the investigative interface is being applied will be adjusted to match the same patient ventilation parameters as recorded during the use of NHF therapy delivered via the comparator interface. Therefore, the settings of the NHF (flow rate, FiO2) will be adjusted according to each patient. At any time during the study, the patient can request to have the investigative interface removed and replaced by the comparator interface. The patient will be constantly monitored during the study using standard practice and at any time during the study the medical and nursing staff can decide to change therapies if they deem that it is in the best interest of the patient.
Intervention code [1] 314602 0
Treatment: Devices
Comparator / control treatment
NHF therapy delivered via the Optiflow+ nasal interface (OPT944, Fisher & Paykel Healthcare) which is a standard, two-prong NHF interface
Control group
Active

Outcomes
Primary outcome [1] 320231 0
Respiratory Rate measured by respiratory inductance plethysmography
Timepoint [1] 320231 0
Assessed just before applying the investigative interface, 30 minutes and 60 minutes following the application of the investigative interface and 30 minutes following the re-application of the standard interface.
Secondary outcome [1] 370932 0
Arterial oxygen saturation. Measured by pulse oximeter.
Timepoint [1] 370932 0
Assessed just before applying the investigative interface, 30 minutes and 60 minutes following the application of the investigative interface and 30 minutes following the re-application of the standard interface.
Secondary outcome [2] 370933 0
Fraction of Inspired Oxygen. Measured by the NHF device.
Timepoint [2] 370933 0
Assessed just before applying the investigative interface, 30 minutes and 60 minutes following the application of the investigative interface and 30 minutes following the re-application of the standard interface.
Secondary outcome [3] 370934 0
Mean gas flow rate. Measured by the NHF device.
Timepoint [3] 370934 0
Assessed just before applying the investigative interface, 30 minutes and 60 minutes following the application of the investigative interface and 30 minutes following the re-application of the standard interface.
Secondary outcome [4] 370935 0
Inspiratory time measured by respiratory inductance plethysmography
Timepoint [4] 370935 0
Assessed just before applying the investigative interface, 30 minutes and 60 minutes following the application of the investigative interface and 30 minutes following the re-application of the standard interface.
Secondary outcome [5] 370936 0
Expiratory time measured by respiratory inductance plethysmography
Timepoint [5] 370936 0
Assessed just before applying the investigative interface, 30 minutes and 60 minutes following the application of the investigative interface and 30 minutes following the re-application of the standard interface.
Secondary outcome [6] 370937 0
Inspiratory time/Expiratory time ratio (I/E ratio) measured by respiratory inductance plethysmography
Timepoint [6] 370937 0
Assessed just before applying the investigative interface, 30 minutes and 60 minutes following the application of the investigative interface and 30 minutes following the re-application of the standard interface.
Secondary outcome [7] 370938 0
Relative change in tidal volume measured by respiratory inductance plethysmography
Timepoint [7] 370938 0
Assessed just before applying the investigative interface, 30 minutes and 60 minutes following the application of the investigative interface and 30 minutes following the re-application of the standard interface.
Secondary outcome [8] 370939 0
Adherence to therapy. Whether the patient wears the mask for the duration of the 1 hour.
Timepoint [8] 370939 0
Assessed by research staff and recorded as whether the patient wears the mask for the duration of the 1 hour.

Eligibility
Key inclusion criteria
1. Patient is receiving NHF therapy with Optiflow+ nasal interface
2. Nasal High Flow rate >/= 30 L·min-1
3. FiO2 is between 0.21 and 0.80
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Less than 18 years’ old
2. Hemodynamic instability
3. Respiratory failure secondary to cardiac failure
4. Neurological or neuromuscular pathologies and/or known phrenic nerve dysfunction
5. Clinician deems patient will not be stable for the duration of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
N/A
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
Up to 30 participants will be enrolled in the study which allows for a potential failure rate of 50 % and a final sample size of 15 subjects. Repeated measures One-Way Analysis of Variance and Paired t-test will be used to analyse the patient data. A P-value of < 0.05 will be considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/06/2019
Actual
3/07/2019
Date of last participant enrolment
Anticipated
1/01/2021
Actual
18/01/2021
Date of last data collection
Anticipated
1/01/2021
Actual
18/01/2021
Sample size
Target
30
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 21533 0
New Zealand
State/province [1] 21533 0
Auckland

Funding & Sponsors
Funding source category [1] 302899 0
Commercial sector/Industry
Name [1] 302899 0
Fisher & Paykel Healthcare
Country [1] 302899 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country
New Zealand
Secondary sponsor category [1] 302853 0
None
Name [1] 302853 0
Address [1] 302853 0
Country [1] 302853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303470 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 303470 0
Ethics committee country [1] 303470 0
New Zealand
Date submitted for ethics approval [1] 303470 0
Approval date [1] 303470 0
28/02/2019
Ethics approval number [1] 303470 0
18/NTA/194

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

Contacts
Principal investigator
Name 93770 0
Dr Anthony Williams
Address 93770 0
Critical Care Complex
Middlemore Hospital
Private Bag 93311
Otahuhu 1640
Country 93770 0
New Zealand
Phone 93770 0
+64 9 2760112
Fax 93770 0
Email 93770 0
tony.williams@cmdhb.org.nz
Contact person for public queries
Name 93771 0
Anthony Williams
Address 93771 0
Critical Care Complex
Middlemore Hospital
Private Bag 93311
Otahuhu 1640
Country 93771 0
New Zealand
Phone 93771 0
+64 9 2760112
Fax 93771 0
Email 93771 0
tony.williams@cmdhb.org.nz
Contact person for scientific queries
Name 93772 0
Stanislav Tatkov
Address 93772 0
Fisher & Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland 2013
Country 93772 0
New Zealand
Phone 93772 0
+64 9 574 0123
Fax 93772 0
Email 93772 0
stanislav.tatkov@fphcare.co.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.