ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619001446156

Ethics application status

Approved

Date submitted

10/09/2019

Date registered

18/10/2019

Date last updated

11/10/2021

Date data sharing statement initially provided

18/10/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

A crossover trial to investigate bag mask ventilation over the Switching Interface, in adult patients undergoing general anaesthesia for elective surgery.

Scientific title

A prospective, randomised, interventional, crossover, pilot study to assess whether bag mask ventilation in the presence of a Switching Interface is acceptable to anaesthetists.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1223-6906

Trial acronym

Linked study record

Health condition

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

Airway management during general anaesthesia

Condition category

Condition code

Anaesthesiology

Anaesthetics

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This is a prospective, randomised, interventional, crossover pilot study. Participants in this study will receive the conventional treatment once and the interventional treatment once, in a randomised order immediately after anaesthetic induction but prior to the procedure (delivered by the anaesthetist):
o Conventional treatment – Bag mask ventilation (BMV) alone (75 seconds).
o Interventional treatment – BMV with the Switching Interface in place (75 seconds).
The conventional and interventional treatments are both forms of non-invasive techniques that deliver oxygen. BMV uses a facemask that forms a tight seal over the mouth and nose, whereas, the Switching Interface is an open system that uses prongs to deliver oxygen through the nose. The treatments will be delivered sequentially without a washout period.

This study will use an intention to treat analysis, however, any deviations from the protocol will be noted in case report forms by the research coordinator.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Patients will also receive the control treatment (BMV alone) after anaesthetic induction.

Control group

Active

Outcomes

Primary outcome [1]

Acceptability of bag mask ventilation (Yes/No) as assessed by the anaesthetist.

Timepoint [1]

Patients in this study will be undergoing elective surgery, the duration of which will vary depending on the type of procedure. Participation in this study will account for 2 minutes and 30 seconds of the total procedure time. The anaesthetist will be asked to complete a questionnaire within 1 hour after the end of the case or when the workload allows. The anaesthetist will complete one questionnaire per patient.

Primary outcome [2]

Peak facemask pressure when bag mask ventilation is performed over the Switching Interface, without exceeding safety pressures (Alicat Pressure Sensor; pressures will not exceed the greater of 30cm.H2O or 10cm.H2O above the adjustable pressure limiting valve for more than 2.5 seconds).

Timepoint [2]

Patients in this study will be undergoing elective surgery, the duration of which will vary depending on the type of procedure. Participation in this study will account for 2 minutes and 30 seconds of the total procedure time. The approximate time until the end of the study case following the administration of the first treatment (conventional or interventional) will be 30 minutes. This is a primary safety outcome to ensure that the peak facemask pressure remains within the acceptable safety boundaries. For this reason, the pressure will be automatically recorded from the time when the patient becomes apnoeic until the end of the study case.

Secondary outcome [1]

Ease of bag mask ventilation as determined by the anaesthetist n a 5 point Likert Scale.

Timepoint [1]

Patients in this study will be undergoing elective surgery, the duration of which will vary depending on the type of procedure. Participation in this study will account for 2 minutes and 30 seconds of the total procedure time. The anaesthetist will be asked to complete a questionnaire within 1 hour after the end of the case or when the workload allows. The anaesthetist will complete one questionnaire per patient.

Secondary outcome [2]

Using ETCO2, could you determine airway patency with the Switching Interface in place (yes/no).

Timepoint [2]

Patients in this study will be undergoing elective surgery, the duration of which will vary depending on the type of procedure. Participation in this study will account for 2 minutes and 30 seconds of the total procedure time. The anaesthetist will be asked to complete a questionnaire within 1 hour after the end of the case or when the workload allows. The anaesthetist will complete one questionnaire per patient.

Secondary outcome [3]

The ability to secure an airway with the Switching Interface in place (Yes/No).

Timepoint [3]

Patients in this study will be undergoing elective surgery, the duration of which will vary depending on the type of procedure. Participation in this study will account for 2 minutes and 30 seconds of the total procedure time. A member of the research team will record this information in the case report form anytime before the end of the study case.

Secondary outcome [4]

Pressure in the facemask cuff (Alicat Pressure Sensor).

Timepoint [4]

Patients in this study will be undergoing elective surgery, the duration of which will vary depending on the type of procedure. Participation in this study will account for 2 minutes and 30 seconds of the total procedure time. The approximate time until the end of the study case following the administration of the first treatment (conventional or interventional) will be 30 minutes. Pressure in the facemask cuff will be automatically recorded from the time when the patient becomes apnoeic until the end of the study case.

Secondary outcome [5]

Pressure in the dryline (Alicat Pressure Sensor).

Timepoint [5]

Patients in this study will be undergoing elective surgery, the duration of which will vary depending on the type of procedure. Participation in this study will account for 2 minutes and 30 seconds of the total procedure time. The approximate time until the end of the study case following the administration of the first treatment (conventional or interventional) will be 30 minutes. Pressure in the facemask dryline will be automatically recorded from the time when the patient becomes apnoeic until the end of the study case.

Secondary outcome [6]

The change in Et-CO2 values (Masimo ISA OR+ monitor).

Timepoint [6]

This will be measured when the patient receives bag mask ventilation (before and after anaesthetic induction).

Secondary outcome [7]

Residual flow through the Switching Interface (Rhodes Engineering PFM).

Timepoint [7]

Patients in this study will be undergoing elective surgery, the duration of which will vary depending on the type of procedure. Participation in this study will account for 2 minutes and 30 seconds of the total procedure time. The approximate time until the end of the study case following the administration of the first treatment (conventional or interventional) will be 30 minutes. Flow through the Switching Interface will be measured from the time the patient enters the OR until the end of the study case.

Eligibility

Key inclusion criteria

1) Provide written informed consent.
2) Having elective surgery under general anaesthesia with intravenous induction in an
operating room with a participating anaesthetist..
3) BMI must be less than 35 kgm-2.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

1) Patients in whom CPAP is contraindicated (e.g. pneumothorax, bullous lung disease, craniofacial trauma, airway, foreign body, unstable haemodynamics)
2) Pre-existing nasal obstruction.
3) Pre-existing hypoxaemia (Oxygen Saturation less than or equal to 89%).
4) Known cyanotic congenital heart disease.
5) Patients undergoing induction with volatile anaesthetics.
6) Patients undergoing caesarean section.
7) Bleeding in the nose or oropharynx.
8) Patients requiring preoperative oxygen therapy secondary to chronic lung disease.
9) Uncontrolled cardiac arrhythmias.
10) Uncontrolled heart failure.
11) Patients with known allergies to anaesthetic agents.
12) Severe hypertension (diastolic blood pressure greater than 120 mmHg).
13) Patients with unstable angina or a recent ( 6 or fewer months) myocardial infarction.
14) Current pulmonary embolism.
15) Symptomatic severe aortic stenosis.
16) Patients in whom a high FiO2 is contradicted (e.g. patients treated with Bleomycin).
17) Patients undergoing procedures with electrocautery or lasers.
18) Patients at risk of aspiration including those who are not fasted or those undergoing rapid sequence induction.
19) Patients where bag mask ventilation is not possible.
20) Patients with oesophageal reflux disease

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)

Sealed envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Crossover

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

23/02/2020

Actual

24/02/2020

Date of last participant enrolment

Anticipated

31/03/2020

Actual

19/04/2021

Date of last data collection

Anticipated

31/03/2020

Actual

19/04/2021

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Fisher & Paykel Healthcare

Address [1]

15 Maurice Paykel Place East Tamaki Auckland 2013

Country [1]

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]

University

Name [1]

University of Auckland

Address [1]

Faculty of Medical and Health Sciences The University of Auckland Private Bag 92019 Auckland 1142

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern A Health and Disability Ethics Committee

Ethics committee address [1]

Ministry of Health
Unisys Building (Level 3, Rangitoto Room)
650 Great South Road
Penrose,1061
Auckland

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

21/08/2019

Approval date [1]

22/11/2019

Ethics approval number [1]

Summary

Brief summary

NHF therapy has been used in the hospital for patients requiring respiratory support, for over a decade. It can deliver 100% oxygen at flow rates up to 70 l.min-1 through an unsealed, wide-bore nasal interface (“prongs”). These high flows are tolerable due to the gas being humidified. Recently, this technique has been introduced in general anaesthesia to ventilate the patient. A potential limitation of the technique is that it cannot be used simultaneously with bag mask ventilation (BMV), which is the standard care in anaesthetic practice. This is because the anaesthetic mask is unable to be sealed over the nasal cannula and flow from the nasal interface can interfere with both monitoring and BMV.
The objective of this study is to evaluate whether a newly designed nasal interface that allows NHF and BMV to be administered interchangeably provides an improvement in the ease-of-use relative to the existing NHF interface and does so at appropriate pressures.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Alan Merry

Address

Faculty of Medical and Health Sciences The University of Auckland Private Bag 92019 Auckland 1142

Country

New Zealand

Phone

+64 9 923 5751

Fax

[email protected]

Contact person for public queries

Name

Tafadzwa Nhemachena

Address

Fisher&Paykel Healthcare 15 Maurice Paykel Place Auckland 2013

Country

New Zealand

Phone

+64 95740100

Fax

[email protected]

Contact person for scientific queries

Name

Tafadzwa Nhemachena

Address

Fisher&Paykel Healthcare 15 Maurice Paykel Place Auckland 2013

Country

New Zealand

Phone

+64 95740100

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• 1. Investigators with applicable consents and ethical approvals.
2. Regulatory bodies

Conditions for requesting access:
• -

What individual participant data might be shared?

• Data related to the primary and secondary outcomes that is in practical form for sharing (for example, acceptability of BMV, peak facemask pressure or ease of BMV).

What types of analyses could be done with individual participant data?

• 1. Meta-analyses or similar reviews
2. Data verification

When can requests for individual participant data be made (start and end dates)?

From:
From the completion of the trial for a minimum of 5 years and a maximum of 10 years.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• Following a written request, if the Principal Investigator and Sponsor both approve, then data would be made available as anonymised electronic records.

For any queries please contact:
Name: TJ Nhemachena
Phone: +64 9 574 0123 Ext: 7906
Email: [email protected]

Are there extra considerations when requesting access to individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
4685	Study protocol			[email protected]

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.

Trial Review

Documents added manually

Documents added automatically