ANZCTR - Registration

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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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Oxygen therapy

Condition category

Condition code

Respiratory

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]

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]

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]

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]

To assess the effects of different trials on the respiratory drive of the subjects

Timepoint [1]

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]

To assess the effects of different interfaces and settings on the respiratory effort of the subjects

Timepoint [2]

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]

To assess subject's comfort with different devices and settings

Timepoint [3]

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

Sex

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

6/11/2017

Actual

12/12/2017

Date of last participant enrolment

Anticipated

30/01/2018

Actual

13/02/2018

Date of last data collection

Anticipated

30/01/2018

Actual

13/02/2018

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia

Address [1]

Viale Europa - Loc. Germaneto 88100 Catanzaro

Country [1]

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]

Individual

Name [1]

Paolo Navalesi

Address [1]

Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia
Viale Europa - Loc. Germaneto 88100, Catanzaro

Country [1]

Italy

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comitato Etico sezione Centro - Regione Calabria

Ethics committee address [1]

A.O.U. Mater Domini in Via Tommaso Campanella, 115 Catanzaro

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

30/06/2017

Approval date [1]

20/07/2017

Ethics approval number [1]

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

Prof Paolo Navalesi

Address

Dipartimento di Scienze Mediche e Chirurgiche, Università Magna Graecia
Viale Europa - Loc. Germaneto 88100, Catanzaro

Country

Italy

Phone

+393355321910

Fax

pnavalesi@unicz.it

Contact person for public queries

Name

Federico Longhini

Address

SC Anestesia e Rianimazione, Ospedale Sant'Andrea, corso Abbiate 31, 13100 Vercelli

Country

Italy

Phone

+393475395967

Fax

longhini.federico@gmail.com

Contact person for scientific queries

Name

Federico Longhini

Address

SC Anestesia e Rianimazione, Ospedale Sant'Andrea, corso Abbiate 31, 13100 Vercelli

Country

Italy

Phone

+393475395967

Fax

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

How or where can data be obtained?

access subject to approvals by Principal Investigator

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

Source	Title	Year of Publication	DOI
Embase	Evaluation of a new interface combining high-flow nasal cannula and cpap.	2019	https://dx.doi.org/10.4187/respcare.06871

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically