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Trial registered on ANZCTR


Registration number
ACTRN12619000323123
Ethics application status
Approved
Date submitted
10/02/2019
Date registered
4/03/2019
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A safety and efficacy trial of the SureflO2™ oxygen mask which incorporates a visual gas flow indicator into a standard oxygen mask.
Scientific title
A prospective open label non-randomised study to Investigate the safety of a gas flow failure detection device (SureflO2™ oxygen mask) in elective surgical patients.
Secondary ID [1] 297351 0
CT-2016-CTN-03286-1 v1 (TGA CTN)
Universal Trial Number (UTN)
U1111-1228-2504
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oxygen Delivery Errors 311472 0
Airway Management 311709 0
Condition category
Condition code
Respiratory 310111 310111 0 0
Other respiratory disorders / diseases
Anaesthesiology 310330 310330 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study was to evaluate the clinical application of the SureflO2 oxygen mask in a controlled clinical setting before widespread clinical use. The intended purpose of the device is to monitor the delivery of oxygen to a patient’s airway. The mask is single use. The indicator dynamically confirms gas flow from a distant source into the oxygen face mask. GMDN code 35171.The device was to be used in 250 patients undergoing anaesthetic procedures and its utility and reliability of function observed in the clinical setting. The primary endpoint/outcome was confirmation of reliable function of the device as a visual indicator of oxygen flow as intended in the perioperative clinical setting with identification of any technical or user issues.
This trial was performed within the operating theatre suite at a large tertiary teaching hospital in Melbourne (St Vincent's Melbourne).
All staff involved in the study participated in a training session conducted by the Principal Investigator/Sponsor/Research Nurse. Staff involved in delivering the intervention were either Consultant Specialist Anaesthetists or accredited Anaesthetic Trainee Doctors.
Patients who were considered eligible for the study were invited to participate face to face by an accredited research nurse. Following signing of the Participant Informed Consent Form (PICF), the patient’s eligibility was confirmed and the patient was enrolled in the study.
On the day of the procedure participants were treated, in all regards, in the same manner as outside the trial and received standard of care anaesthetic assessment and management.
For participants who received regional or local anaesthesia (RA/LA), use of the SureflO2 oxygen mask commenced in the Anaesthetic Room as soon as pre-operative sedation had been administered and continued throughout surgery and the period in the PACU.
For participants who received a general anaesthetic (GA), the delivery of supplemental oxygen during surgery is typically achieved via an alternate ‘invasive’ airway device (Laryngeal Mask/Endotracheal Tube) connected to the Anaesthetic machine and therefore the SureflO2 oxygen mask was not utilised during this period.
At the conclusion of surgery, for participants who received a GA, the delivery of supplemental oxygen was transitioned to the SureflO2 oxygen mask connected to a portable Oxygen Cylinder (OC) and continued during patient transport from the operating theatre to the PACU.
There were 249 patients enrolled over the eleven weeks and one day of the trial.
Results of the intervention were populated on a secure on-line survey platform and a full time research nurse was dedicated to the study during its implementation to ensure adherence to protocol and recording of results.
Intervention code [1] 313601 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319006 0
The anaesthetists' perception of successful or not successful detection of oxygen flow by the device as recorded on a secure online study-specific questionnaire.
Timepoint [1] 319006 0
Immediately upon application of the intervention and for the duration of use of the mask.
Primary outcome [2] 319007 0
Adverse events serious or non-serious. For example mechanical failure of the device posing an airway risk. A further example would be user technique error in the case of the device being difficult to interpret. Adverse events were to be logged by trained users of the device in the study and the overseeing study nurse and logged onto an online platform. In addition the senior investigator was available at all time in the event of a serious adverse event.
Timepoint [2] 319007 0
Immediately upon application of the intervention and for the duration of use of the mask.
Secondary outcome [1] 366703 0
Oxygen delivery failure events as assessed and recorded by the anaesthetist administering supplemental oxygen with data entered via the online tool.
Timepoint [1] 366703 0
Immediately upon application of the intervention and for the duration of use of the mask.

Eligibility
Key inclusion criteria
* All operative patients scheduled for procedures requiring general anaesthesia OR sedation (in association with local/regional/neuraxial anaesthetic techniques)

* Any patient requiring perioperative oxygen supplementation via medium concentration oxygen mask

* Elective planned surgical patients (no emergencies or non-elective cases).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

* Patients under 18 or over 18 and not capable of consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
For participants who received regional or local anaesthesia (RA/LA), use of the SureflO2 oxygen mask commenced in the Anaesthetic Room as soon as pre-operative sedation had been administered and continued throughout surgery and the period in the PACU.

For participants who received a general anaesthetic (GA), the delivery of supplemental oxygen during surgery is typically achieved via an alternate ‘invasive’ airway device (Laryngeal Mask/Endotracheal Tube) connected to the Anaesthetic machine and therefore the SureflO2 oxygen mask was not utilised during this period.

At the conclusion of surgery, for participants who received a GA, the delivery of supplemental oxygen was transitioned to the SureflO2 oxygen mask connected to a portable Oxygen Cylinder (OC) and continued during patient transport from the operating theatre to the PACU.
Phase
Type of endpoint/s
Safety
Statistical methods / analysis
An acceptable limit of the functioning success rate was assumed to be 97.5% (ie the lower limit of the 95% binomial confidence interval for the functioning success rate). The occurrence of at least one functioning failure was also assumed. At least 200 subjects are required to obtain a 95% confidence interval with a lower limit of 97.5%, when at least one functioning failure occurs.
A sample size of 248 was determined to be required to ensure that a two-sided Fisher’s Exact test and a=0.05 has 90% power to detect an absolute difference of 5% in the rate of patients suffering a failure of oxygen delivery event compared with historical audit data revealing a 6.3% rate of failure. This number of subjects also provides a large enough sample size to estimate a 95% confidence interval for the device function success rate assuming at least one failure and a lower 95% confidence limit of 97.5%.
Two-hundred and fifty participants were to be enrolled into the study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/04/2017
Date of last participant enrolment
Anticipated
Actual
27/06/2017
Date of last data collection
Anticipated
Actual
27/06/2017
Sample size
Target
250
Accrual to date
Final
249
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13081 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 25590 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 301916 0
Commercial sector/Industry
Name [1] 301916 0
VPAS Group Pty Ltd
Country [1] 301916 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
VPAS Group Pty Ltd
Address
Suite 505, 100 Victoria Parade, East Melbourne, VIC 3002
Country
Australia
Secondary sponsor category [1] 301672 0
None
Name [1] 301672 0
Address [1] 301672 0
Country [1] 301672 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302601 0
St Vincent's Hospital (Melbourne) Human Research Ethics Committee-D
Ethics committee address [1] 302601 0
Ethics committee country [1] 302601 0
Australia
Date submitted for ethics approval [1] 302601 0
20/07/2016
Approval date [1] 302601 0
14/03/2017
Ethics approval number [1] 302601 0
HREC 0124/16

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

Contacts
Principal investigator
Name 90782 0
Dr Matthew Matusik
Address 90782 0
Victoria Parade Anaesthetic Services
Suite 505/100 Victoria Parade
East Melbourne Victoria 3002
Country 90782 0
Australia
Phone 90782 0
+61 417548633
Fax 90782 0
Email 90782 0
SureflO2@vpasgroup.com
Contact person for public queries
Name 90783 0
Matthew Matusik
Address 90783 0
Victoria Parade Anaesthetic Services
Suite 505/100 Victoria Parade
East Melbourne Victoria 3002
Country 90783 0
Australia
Phone 90783 0
+61 417548633
Fax 90783 0
Email 90783 0
SureflO2@vpasgroup.com
Contact person for scientific queries
Name 90784 0
Matthew Matusik
Address 90784 0
Victoria Parade Anaesthetic Services
Suite 505/100 Victoria Parade
East Melbourne Victoria 3002
Country 90784 0
Australia
Phone 90784 0
+61 417548633
Fax 90784 0
Email 90784 0
SureflO2@vpasgroup.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
In the event of request for raw de-identified data, we will consider sharing on a case by case basis.


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
No additional documents have been identified.