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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] 298138 0
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 314314 0
Condition category
Condition code
Anaesthesiology 312666 312666 0 0
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] 315502 0
Treatment: Devices
Comparator / control treatment
Patients will also receive the control treatment (BMV alone) after anaesthetic induction.
Control group
Active

Outcomes
Primary outcome [1] 321315 0
Acceptability of bag mask ventilation (Yes/No) as assessed by the anaesthetist.
Timepoint [1] 321315 0
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] 321316 0
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] 321316 0
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] 374619 0
Ease of bag mask ventilation as determined by the anaesthetist n a 5 point Likert Scale.
Timepoint [1] 374619 0
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] 374620 0
Using ETCO2, could you determine airway patency with the Switching Interface in place (yes/no).
Timepoint [2] 374620 0
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] 374621 0
The ability to secure an airway with the Switching Interface in place (Yes/No).
Timepoint [3] 374621 0
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] 374624 0
Pressure in the facemask cuff (Alicat Pressure Sensor).
Timepoint [4] 374624 0
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] 374625 0
Pressure in the dryline (Alicat Pressure Sensor).
Timepoint [5] 374625 0
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] 374634 0
The change in Et-CO2 values (Masimo ISA OR+ monitor).
Timepoint [6] 374634 0
This will be measured when the patient receives bag mask ventilation (before and after anaesthetic induction).
Secondary outcome [7] 374635 0
Residual flow through the Switching Interface (Rhodes Engineering PFM).
Timepoint [7] 374635 0
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?
No
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
50
Accrual to date
Final
49
Recruitment outside Australia
Country [1] 21847 0
New Zealand
State/province [1] 21847 0

Funding & Sponsors
Funding source category [1] 302666 0
Commercial sector/Industry
Name [1] 302666 0
Fisher & Paykel Healthcare
Country [1] 302666 0
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] 302596 0
University
Name [1] 302596 0
University of Auckland
Address [1] 302596 0
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 302596 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303289 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 303289 0
Ethics committee country [1] 303289 0
New Zealand
Date submitted for ethics approval [1] 303289 0
21/08/2019
Approval date [1] 303289 0
22/11/2019
Ethics approval number [1] 303289 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93146 0
Prof Alan Merry
Address 93146 0
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
Country 93146 0
New Zealand
Phone 93146 0
+64 9 923 5751
Fax 93146 0
Email 93146 0
a.merry@auckland.ac.nz
Contact person for public queries
Name 93147 0
Tafadzwa Nhemachena
Address 93147 0
Fisher&Paykel Healthcare
15 Maurice Paykel Place
Auckland 2013
Country 93147 0
New Zealand
Phone 93147 0
+64 95740100
Fax 93147 0
Email 93147 0
tj.nhemachena@fphcare.co.nz
Contact person for scientific queries
Name 93148 0
Tafadzwa Nhemachena
Address 93148 0
Fisher&Paykel Healthcare
15 Maurice Paykel Place
Auckland 2013
Country 93148 0
New Zealand
Phone 93148 0
+64 95740100
Fax 93148 0
Email 93148 0
tj.nhemachena@fphcare.co.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will 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).
When will data be available (start and end dates)?
From the completion of the trial for a minimum of 5 years and a maximum of 10 years.
Available to whom?
1. Investigators with applicable consents and ethical approvals.
2. Regulatory bodies
Available for what types of analyses?
1. Meta-analyses or similar reviews
2. Data verification
How or where can data be obtained?
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: Tj.Nhemanchena@fphcare.co.nz


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4685Study protocol  tj.nhemachena@fphcare.co.nz



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.