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Trial registered on ANZCTR


Registration number
ACTRN12617001600336
Ethics application status
Approved
Date submitted
13/11/2017
Date registered
6/12/2017
Date last updated
13/11/2018
Date data sharing statement initially provided
13/11/2018
Date results information initially provided
13/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comfort comparison of two bi-level devices in patients with chronic respiratory diseases.
Scientific title
Comfort comparison of two bi-level devices in patients with chronic respiratory diseases.
Secondary ID [1] 293351 0
nil
Universal Trial Number (UTN)
U1111-1203-5433
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 305458 0
chronic respiratory diseases 305459 0
Condition category
Condition code
Respiratory 304726 304726 0 0
Other respiratory disorders / diseases
Respiratory 304775 304775 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention Bi-level device is a new Fisher and Paykel Healthcare (FPH) bi-level device, administered for 30 minutes. Device mode will be set to bi-level Spontaneous/Timed (ST) mode. Humidity is not to be used. The device will be setup to provide the following as per the British Thoracic Society (BTS) guidelines:
• Inspiratory Positive Airways Pressure (IPAP) 15 cmH2O
• Expiratory Positive Airways Pressure (EPAP) 4 cmH2O

Note, British Thoracic Society guidelines recommend a starting EPAP of 3 cmH2O. 4 cmH2O will be used as an alternative as this is the lowest pressure the machine can provide. No supplemental oxygen is to be used with the device and no ramp function will be utilised.
Advanced device setting will be set to the following
• Rise time 200ms
• Fall time 200ms
• Triggering medium (6.0 lpm)
• Backup rate 4
• Inspiratory Time 1 second
The Non-invasive ventilation (NIV) mask will be sized according to the mask user instructions. The mask will be fitted to the participant and adjusted to minimise any leaks. The order of allocation of the 2 interventions will be randomised. During the rest period of at least 15 minutes after intervention 1, the participant will be asked to complete a questionnaire about their experience of each device. After intervention 2, the questionnaire will be repeated and trial completed with no further rest period required.
Intervention code [1] 299605 0
Treatment: Devices
Comparator / control treatment
Resmed stellar bi-level device for 30mins. Device mode will be set to bi-level ST. Humidity is not to be used. The device will be setup to provide the following as per the BTS guidelines:
• IPAP 15 cmH2O
• EPAP 4 cmH2O

Note, BTS (2016) guidelines recommend a starting EPAP of 3 cmH2O. 4 cmH2O will be used as an alternative as this is the lowest pressure the machine can provide. No supplemental oxygen is to be used with the device and no ramp function will be utilised.
Advanced device setting will be set to the following
• Rise time 200ms
• Fall time 200ms
• Triggering medium (6.0 lpm)
• Backup rate 4
• Inspiratory Time 1 second
The NIV mask will be sized according to the mask user instructions. The mask will be fitted to the participant and adjusted to minimise any leaks
Control group
Active

Outcomes
Primary outcome [1] 303935 0
Difference in 'global tolerability score' found by averaging four comfort scores ie the answers to four questions, as assessed by participants on a Visual Analogue Scale (VAS). The four questions refer to: 1) overall comfort, 2) overall breathing/pressure change synchrony 3) pressure comfort on inspiration 4) pressure comfort on expiration, The VAS is a continuous 100mm scale with 0 being the most “negative” and 100 being the most “positive”.
Timepoint [1] 303935 0
30 minutes
Secondary outcome [1] 340500 0
PtCO2 at 5 minute intervals during the intervention, adjusted for baseline. Note: Baseline is the measurement taken at t=0 at the start of each intervention. Intervention number 2 will have a baseline +/- 4mmHg from baseline for Intervention 1. This will be measured on a Sentec transcutaneous monitor.
Timepoint [1] 340500 0
5 minute intervals (t=5, t=10, t=15 up to t=30).
Secondary outcome [2] 340501 0
Oxygen saturation at 5 minute intervals during the intervention, adjusted for baseline*.
* Baseline is the measurement taken at t=0 at the start of each intervention. Intervention number 2 will have a baseline +/- 4mmHg from baseline for Intervention 1. This will be measured on a Sentec transcutaneous monitor.
Timepoint [2] 340501 0
5 minute intervals (t=5, t=10, t=15 up to and including t=30) and at the end of the subsequent 15 minute washout period.
Secondary outcome [3] 340502 0
Heart rate at 5 minute intervals during the intervention, adjusted for baseline*.
* Baseline is the measurement taken at t=0 at the start of each intervention. Intervention number 2 will have a baseline +/- 4mmHg from baseline for Intervention 1. This will be measured on a Sentec transcutaneous monitor.
Timepoint [3] 340502 0
5 minute intervals (t=5, t=10, t=15 up to and including t=30) and at the end of the subsequent 15 minute washout period.
Secondary outcome [4] 340503 0
Respiratory rate at 5 minute intervals during the intervention, adjusted for baseline*.
* Baseline is the measurement taken at t=0 at the start of each intervention. Intervention number 2 will have a baseline +/- 4mmHg from baseline for Intervention 1. This will be counted by the investigator over the preceding 1 minute before each 5 minute time-point.
Timepoint [4] 340503 0
5 minute intervals (t=5, t=10, t=15 up to and including t=30) and at the end of the subsequent 15 minute washout period.
Secondary outcome [5] 340504 0
Arterial blood pressure (mean, systolic and diastolic all measured in mmHg) measured with a standard automated blood pressure cuff and measuring device.
Timepoint [5] 340504 0
Measured at t=0 and 30 minutes.
Secondary outcome [6] 340505 0
Three Other Tolerability questionnaire (designed for the study) results
Timepoint [6] 340505 0
Tolerability questionnaires will be administered at the end of each intervention in the washout period (between t=30 and t=45mins)
Secondary outcome [7] 340506 0
Patient ventilator asynchrony scoring, scored from pressure and flow waveforms.
Timepoint [7] 340506 0
Continuous over 30 minutes
Secondary outcome [8] 340507 0
Observed moisture in the mask or castle port by investigator for each intervention.
Timepoint [8] 340507 0
t=30mins

Eligibility
Key inclusion criteria
• Aged 18+
• Patients diagnosed with chronic respiratory diseases associated with chronic respiratory failure
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Significant hypoxia
o StO2 < 88 % after 20-30 minutes of Sentec stabilisation or for a sustained period during the intervention (according to investigators clinical discretion)
• Chronic respiratory disease that is not deemed to be stable
o Current exacerbation requiring acute treatment with a short course of antibiotics/oral steroids within the last 1 week
o Hospital admission for an acute exacerbation in the last 2 weeks
• Recent cardiac or respiratory arrest
• Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
• Coma, decreased level of consciousness or agitation
• Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
• Cerebrospinal fluid leak, abnormalities of the cribriform plate or prior history of head trauma.
• Use of supplemental oxygen
• Fluid depletion, poor left ventricular function or cardiac disease without adequate pharmacological therapy
• Pneumothorax, or at high clinical risk of pneumothorax or barotrauma due to, for example, previous pneumothorax, pneumomediastinum, severe bullous lung disease, acute lung injury secondary to pneumonia, interstitial lung diseases, cystic fibrosis and neuromuscular disease
• Diagnosis of a notifiable disease
• Use of an implantable medical device
• Have any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results

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)
The randomisation code will be stored in a sealed opaque envelope which will be
opened by the Investigator at randomisation (immediately prior to the first intervention).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation code will be pre-generated by the study statistician by computer.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
Other design features
Randomised controlled 2-way crossover trial. one investigator will carry out each study visit. Participants will not be told in which order they will receive the interventions.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 25 patients is required to demonstrate non-inferiority of the primary outcome (global tolerability score) assuming the devices are equally comfortable, with a significance level of 0.05, 90% power, a standard deviation 1.72 mm and a non-inferiority margin of 25 mm. The assumed standard deviation is based on a similar study conducted by Fisher and Paykel Healtchare (FPH, internal test report TR-27785). To minimise the likelihood of the study being underpowered, patients will be recruited until 30 have completed the protocol.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/12/2017
Actual
19/12/2017
Date of last participant enrolment
Anticipated
9/03/2018
Actual
29/03/2018
Date of last data collection
Anticipated
9/03/2018
Actual
29/03/2018
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 9354 0
New Zealand
State/province [1] 9354 0
Wellington

Funding & Sponsors
Funding source category [1] 297977 0
Commercial sector/Industry
Name [1] 297977 0
Fisher & Paykel Healthcare Ltd
Country [1] 297977 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher & Paykel Healthcare Ltd
Address
15 Maurice Paykel Place, East Tamaki, Auckland 2013, New Zealand
Country
New Zealand
Secondary sponsor category [1] 297044 0
None
Name [1] 297044 0
Address [1] 297044 0
Country [1] 297044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299015 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 299015 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 299015 0
New Zealand
Date submitted for ethics approval [1] 299015 0
26/10/2017
Approval date [1] 299015 0
17/11/2017
Ethics approval number [1] 299015 0
17CEN225

Summary
Brief summary
This study will use a new Fisher and Paykel Healthcare flow generator that is capable of providing bi-level therapy in the pressure range 4 cmH2O to 30 cmH2O. The objective is to establish if patients who suffer from a chronic respiratory disease, that may be treated with bi-level, can determine a comfort preference between the FPH bi-level device and a commercially available bi-level device.
Patients using the device will be awake and testing the device for comfort, attending a single visit lasting around 2-3 hours at the Medical Research Institute of NZ situated at Wellington Regional Hospital. They will undergo lung function testing to assess the capacity and function of their lungs. A small ear clip will be painlessly attached to record partial pressure of transcutaneous carbon dioxide (PtCO2), oxygen saturations and pulse rate.
The study is to be setup such that patients will trial the FPH device and a state of the art bi-level device for 30 minutes each, in randomized order, with a washout period between devices. At the end of each session the patients will be asked a range of questions relating to comfort as well as being asked to complete a range of visual analog scales (VAS). Flow and pressure data will also be recorded in order to allow for off line analysis of ventilator synchrony and pressure delivery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79002 0
Dr Steven McKinstry
Address 79002 0
Medical Research Institute of New Zealand Level 7 CSB Wellington
Regional Hospital Riddiford Street Newtown Wellington 6021
Country 79002 0
New Zealand
Phone 79002 0
+64 4 805 0261
Fax 79002 0
Email 79002 0
[email protected]
Contact person for public queries
Name 79003 0
Steven McKinstry
Address 79003 0
Medical Research Institute of New Zealand Level 7 CSB Wellington
Regional Hospital Riddiford Street Newtown Wellington 6021
Country 79003 0
New Zealand
Phone 79003 0
+64 4 805 0261
Fax 79003 0
Email 79003 0
[email protected]
Contact person for scientific queries
Name 79004 0
Steven McKinstry
Address 79004 0
Medical Research Institute of New Zealand Level 7 CSB Wellington
Regional Hospital Riddiford Street Newtown Wellington 6021
Country 79004 0
New Zealand
Phone 79004 0
+64 4 805 0261
Fax 79004 0
Email 79004 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the results reported in this article, after de-identification (test, tables, figures and appendices) are available immediately after publication for 36 months, from the corresponding author on reasonable request.
When will data be available (start and end dates)?
immediately after publication for 36 months, from the corresponding author on reasonable request.
Available to whom?
The data will be available to Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose and for any analyses.
Available for what types of analyses?
Any analyses
How or where can data be obtained?
Information regarding submitting proposal and accessing data may be found by e-mailing the corresponding author.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 373986-(Uploaded-12-11-2018-12-46-14)-Basic results summary.docx
Plain language summaryNo The comfort of a device in treating respiratory fa... [More Details]

Documents added automatically
No additional documents have been identified.