ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000047796

Ethics application status

Approved

Date submitted

24/12/2012

Date registered

15/01/2013

Date last updated

1/10/2015

Type of registration

Prospectively registered

Titles & IDs

Public title

A study of super-high flow oxygen therapy in healthy volunteers and its effect on the lungs - the SHOT study

Scientific title

A study in healthy volunteers to describe the airway pressures generated by a wide range of flows provided by high flow humidified nasal oxygen therapy and the effect on regional lung ventilation

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U-1111-1137-3324

Trial acronym

The SHOT study

Linked study record

Health condition

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

Respiratory

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

15 healthy subjects will be included in this study.

A 10 F catheter will be inserted into the hypopharynx via the nose. Following this the position of the tube will be confirmed using end tidal CO2 monitoring as well as a visual inspection.

Following the diagnostic setup they will be attached to the Optiflow TRADEMARK system comprising the Fisher and Paykel Healthcare MR880 humidifier delivering gas heated and humidified to 37degrees C, 44mg H2O/L. The heated circuit will comprise an RT241 circuit, an MR290 autofeed chamber and an appropriately sized adult nasal interface.

Subjects will also be assessed with EIT. For this purpose there will be a circumferential placement of a 16 electrode belt applied around the torso. The electrodes will be attached to the skin and can be removed without resulting damage or discomfort at any stage.

Participants will have pressure measurements carried out at 30, 40, 50, 60, 70, 80, 90 and 100 L/min in random order. Pressure measurement for each flow will be recorded over one minute of breathing using precision pressure transducer (PPT).
This procedure is expected to take around 60 mins. The catheter will be removed at the end of this period.

Hypopharyngeal pressure will be measured using a Honeywell precision pressure transducer (PPT – 0001 DWWW2VA-B, Honeywell International Ltd) with a laptop computer interface. The hypopharyngeal pressures will be recorded over one minute of breathing. The mean airway pressure will be determined by averaging the pressure from the peak of inspiration of the first to the last breath within the one minute recording. This will allow the entire pressure profile of each breath to be included within the mean airway pressure calculation.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Uncontrolled

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To describe the relationship between flow and/or pressure delivered and mean pressure generated in the airway in a group of healthy subjects. This will be measured in the nasopharynx using a precision pressure transducer.

Timepoint [1]

Over one minute of therapy at each given flow

Secondary outcome [1]

To demonstrate the resulting changes in lung physiology using Electrical Impedance Tomography.

Timepoint [1]

Over one minute while using nasal high flow

Eligibility

Key inclusion criteria

Healthy subjects are eligible for inclusion if all of the following criteria are met: The subject is 18 years or older; Consent has been obtained;There are no known intrathoracic pathologies known ; The subject is not on any regular medication which is known to affect the cardiopulmonary system in any way

Minimum age

18 Years

Maximum age

99 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Healthy subjects will be excluded from the study if one or more of the following criteria are present: The subject has significant nasal septum deviation; High flow nasal oxygen therapy is contraindicated.

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)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

4/02/2013

Actual

20/03/2013

Date of last participant enrolment

Anticipated

Actual

8/04/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

N/A

Address [1]

N/A

Country [1]

Primary sponsor type

Individual

Name

Rachael Parke

Address

Cardiothoracic and Vascular ICU
Auckland City Hospital
Park Road
Auckland
1142

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

Dr Shay McGuinness

Address [1]

Cardiothoracic and Vascular ICU
Auckland City Hospital
Park Road
Auckland
1142

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Diasbility Ethics Committee

Ethics committee address [1]

Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

03/12/2012

Approval date [1]

17/01/2013

Ethics approval number [1]

12/CEN/79

Summary

Brief summary

High flow humidified nasal oxygen therapy (HFNOT) is a recent development that allows the provision of controlled oxygen concentrations and low levels of positive airway pressure via a nasal interface. The HFNOT system can offer clinicians and patients a different mechanism for delivering such pressure, at low levels, without some of the complications and comfort issues associated with these other methods. Some of the reported risks associated with face mask non invasive ventilation include mask discomfort, nasal dryness, oral dryness and eye irritation nasal or eye trauma and gastric distension / aspiration. Over the last three years there have been several studies published regarding the effectiveness and the clinical effect of this new form of respiratory support. Currently HFNOT is used as the standard therapy in patients with mild to moderate hypoxemic respiratory failure requiring respiratory support following extubation to improve oxygenation in patients in the Cardiothoracic and Vascular Intensive Care Unit at Auckland City Hospital. Research conducted previously by our group and others has demonstrated a positive linear correlation between the amount of flow and the resulting airway pressure with flows in the range described above. Since it is technically possible to apply higher flows with HFNOT devices we would like to describe the resulting changes in airway pressure and to see if the correlation remains linear at flows exceeding 50L/min and would like to conduct an initial study on 15 healthy volunteers.

Trial website

Trial related presentations / publications

Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers.

Parke RL, Bloch A, McGuinness SP.
Respir Care. 2015 Sep 1. pii: respcare.04028. [Epub ahead of print]
PMID: 26329355 [PubMed - as supplied by publisher]

Public notes

Contacts

Principal investigator

Name

Mrs Rachael Parke

Address

Cardiothoracic and Vascular ICU
Auckland City Hospital
Park Road
Auckland 1142

Country

New Zealand

Phone

+6421893176

Fax

rparke@adhb.govt.nz

Contact person for public queries

Name

Rachael Parke

Address

Cardiothoracic and Vascular ICU
Auckland City Hospital
Park Road
Auckland 1142

Country

New Zealand

Phone

+6421893176

Fax

rparke@adhb.govt.nz

Contact person for scientific queries

Name

Rachael Parke

Address

Cardiothoracic and Vascular ICU
Auckland City Hospital
Park Road
Auckland 1142

Country

New Zealand

Phone

+6421893176

Fax

rparke@adhb.govt.nz

No information has been provided regarding IPD availability

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
Dimensions AI	Effect of Very-High-Flow Nasal Therapy on Airway Pressure and End-Expiratory Lung Impedance in Healthy Volunteers	2015	https://doi.org/10.4187/respcare.04028

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