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Trial registered on ANZCTR


Registration number
ACTRN12617001526369
Ethics application status
Approved
Date submitted
12/09/2017
Date registered
3/11/2017
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Date results information initially provided
3/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of a new device for oxygen therapy with continuous positive airway pressure in healthy volunteers
Scientific title
A new interface combining high flow oxygen through nasal cannula and continuous positive airway pressure: comparative assessment of physiological effects in healthy volunteers
Secondary ID [1] 292532 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxygen therapy 304185 0
Condition category
Condition code
Respiratory 303511 303511 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention consists in the simultaneously application of HFNC and CPAP using a new device.
We will invite to participate 14 healthy volunteers (7 male and 7 female), from our ICU staff.
After obtaining written informed consent, volunteers will be seated in upright position.
After anesthetizing the nose with lidocaine, a 10 French suction catheter will be passed via the nose into the oropharynx. We visually confirmed that the manometry catheter tip was just below the uvula. We will also use end-tidal carbon dioxide monitoring to confirm correct placement and catheter patency. The catheter will be connected to a pressure transducer connected to a laptop computer interface. As necessary, the catheter will be adjusted or suctioned to obtain a clear reading.

We will test this new interface combing CPAP (PEEP 10 cmH2O and flow at 60 L/min) and HFNC at increasing flow rates (30, 40, 50 and 60 L/min), performed again with the volunteer's mouth open and closed.
We will use two blenders taking gas flow from wall air and oxygen outlets (one for HFNC and one for CPAP). All trials will be run in room air oxygen concentration.
All pressure measurement will be taken after each flow rate will be established for 15 min, to allow the volunteer to become accustomed to the feeling of different interfaces and to allow the breathing pattern to settle. All recordings will be taken over one minute of quiet breathing. The approximate total duration of the intervention will be around 1 hour. The different flow rate will be consecutively applied.
Intervention code [1] 298723 0
Treatment: Devices
Comparator / control treatment
Control treatments will be 1) HFNC and 2) CPAP.
1) HFNC
After a baseline assessment during spontaneous breathing in room air, the volunteer will start on HFNC (RT033/034 Optiflow nasal cannula, MR880 heated humidifier, and RT241 heated delivery tube, Fisher & Paykel Healthcare, Auckland, New Zealand) once the system reached the set temperature (37°C). Measurements will be then performed with the volunteer's mouth open, and again with the mouth closed, at flows of 30, 40, 50 and 60 L/min. The duration of each flow rate will be 15 minutes, with an approximate overall intervention of 1 hour. The different flow rate will be consecutively applied.

2) CPAP
Afterwards, the volunteer will undergo to helmet CPAP set with a PEEP of 10 cmH2O and flow of 60 L/min, to avoid carbon dioxide re-breathing for 15 minutes. No heated humidification will be applied. Measurements will be then performed with the volunteer's mouth open, and again with the mouth closed.

All trials will be conducted in room air.
Control group
Active

Outcomes
Primary outcome [1] 302888 0
To assess pressures applied to the airways during HFNC, CPAP and a new device combining HFNC and CPAP at varying of the gas flows.
Timepoint [1] 302888 0
All pressure measurements will be taken, through a dedicated catheter inserted in the oro-pharynx, after therapy will be established for 15 min, to allow the volunteer to become accustomed to the feeling of different interfaces and to allow the breathing pattern to settle.
Secondary outcome [1] 337339 0
To assess the effects of different trials on the respiratory drive of the subjects
Timepoint [1] 337339 0
All measurements will be taken with the sonographic assessment of the diaphragm (i.e., cranio-caudal displacement) after therapy will be established for 15 min, to allow the volunteer to become accustomed to the feeling of different interfaces and to allow the breathing pattern to settle.
Secondary outcome [2] 337340 0
To assess the effects of different interfaces and settings on the respiratory effort of the subjects
Timepoint [2] 337340 0
All measurements will be taken with the sonographic assessment of the diaphragm (i.e., thickening fraction) after therapy will be established for 15 min, to allow the volunteer to become accustomed to the feeling of different interfaces and to allow the breathing pattern to settle.
Secondary outcome [3] 337341 0
To assess subject's comfort with different devices and settings
Timepoint [3] 337341 0
Comfort evaluation will be taken through an 11-point Numeric Rating Scale (NRS) on an ICU-adapted large printed scale including numbers and descriptors after therapy will be established for 15 min. Before protocol initiation, all patients will receive a detailed explanation of the NRS. The patients will be asked to evaluate their comfort level, indicating a number between 0 (worst possible comfort) and 10 (best possible comfort).

Eligibility
Key inclusion criteria
14 healthy volunteers (7 male and 7 female)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
contra-indications to pass a catheter into the pharynx (i.e., recent surgery or epistaxis)

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)
All volunteers will undergo to all different devices and settings, applied in random order. The sequence will be hold in sealed, opaque numbered envelops.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence of device and settings application will be generated through a computer by an external statistician not involved in the study. The sequence will be hold in sealed, opaque numbered envelops.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The normal distribution will be ascertained by means of the Kolmogorov-Smirnov test. Continuous data will be presented as mean (standard deviation) or median (interquartile range) depending on normality. The t-test or Kruskal-Wallis test will be used to compare pressures between open and closed mouth groups for inspiration and expiration and between genders. The analysis of variance on ranks for repeated measures (Friedman test) will be used to compare the evaluated continuous variables among different interventions. Pairwise multiple comparisons will be conducted with the post hoc Dunn's method. A p value <0.05 will be considered statistically significant. To evaluate the consistency among sonographic assessment by the investigators, we will use the interclass correlation coefficient.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 9094 0
Italy
State/province [1] 9094 0

Funding & Sponsors
Funding source category [1] 297103 0
University
Name [1] 297103 0
Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia
Address [1] 297103 0
Viale Europa - Loc. Germaneto 88100 Catanzaro
Country [1] 297103 0
Italy
Primary sponsor type
Individual
Name
Federico Longhini
Address
SC Anestesia e Rianimazione, Ospedale Sant'Andrea, corso Abbiate 31, 13100 Vercelli
Country
Italy
Secondary sponsor category [1] 296113 0
Individual
Name [1] 296113 0
Paolo Navalesi
Address [1] 296113 0
Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia
Viale Europa - Loc. Germaneto 88100, Catanzaro
Country [1] 296113 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298279 0
Comitato Etico sezione Centro - Regione Calabria
Ethics committee address [1] 298279 0
A.O.U. Mater Domini in Via Tommaso Campanella, 115 Catanzaro
Ethics committee country [1] 298279 0
Italy
Date submitted for ethics approval [1] 298279 0
30/06/2017
Approval date [1] 298279 0
20/07/2017
Ethics approval number [1] 298279 0

Summary
Brief summary
High flow oxygen therapy through nasal cannula (HFNC) is increasingly used in different clinical situation to assist patients with acute respiratory failure. HFNC is characterized by a low dilution of the administered gas with room air, a dead-space wash out of the upper respiratory airways and the application of a positive end-expiratory pressure (PEEP).
However, PEEP is strictly limited to the during the expiration phase of the respiratory cycle, while during inspiration pharyngeal pressure drops to zero or even to negative values. This could be a limitation in case of hypoxemic acute respiratory failure (hARF), because recruitment of lung regions with atelectasis is not assured during the whole respiratory cycle. With continuous positive airway pressure (CPAP), the patient’s airway is maintained throughout the respiratory cycle at a selected constant pressure (PEEP), which is higher than the atmospheric pressure.
Among the available interfaces, the helmet has been suggested to be effective in improving patient tolerance allowing more prolonged application of continuous CPAP. However, the heated humidification with helmet is problematic, difficult or almost or impossible because of condensation of water inside the interface ("fog" effect). We therefore designed a new interface joining HFNC with CPAP through helmet, to combine the physiological benefit of these two interfaces.
We aim to assess airway pressures during the use of this new device with different gas flows and breathing conditions (primary endpoint). We will also assess the effects of different interfaces on the respiratory drive and effort of the subjects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76574 0
Prof Paolo Navalesi
Address 76574 0
Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia
Viale Europa - Loc. Germaneto 88100, Catanzaro
Country 76574 0
Italy
Phone 76574 0
+393355321910
Fax 76574 0
Email 76574 0
pnavalesi@unicz.it
Contact person for public queries
Name 76575 0
Dr Federico Longhini
Address 76575 0
SC Anestesia e Rianimazione, Ospedale Sant'Andrea, corso Abbiate 31, 13100 Vercelli
Country 76575 0
Italy
Phone 76575 0
+393475395967
Fax 76575 0
Email 76575 0
longhini.federico@gmail.com
Contact person for scientific queries
Name 76576 0
Dr Federico Longhini
Address 76576 0
SC Anestesia e Rianimazione, Ospedale Sant'Andrea, corso Abbiate 31, 13100 Vercelli
Country 76576 0
Italy
Phone 76576 0
+393475395967
Fax 76576 0
Email 76576 0
longhini.federico@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
By what mechanism will data be made available?
access subject to approvals by Principal Investigator
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary