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Trial registered on ANZCTR


Registration number
ACTRN12622001545752
Ethics application status
Not required
Date submitted
31/10/2022
Date registered
13/12/2022
Date last updated
13/12/2022
Date data sharing statement initially provided
13/12/2022
Date results provided
13/12/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
A pilot study comparing oxygen delivery from 4 different delivery devices under hyperbaric conditions on healthy volunteers.
Scientific title
A pilot study comparing oxygen delivery from 4 different delivery devices under hyperbaric conditions on healthy volunteers.
Secondary ID [1] 308312 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
hypoxemia
 328096 0
Condition category
Condition code
Anaesthesiology 325151 325151 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The devices used were:
• “Hans Rudolph” Rudolph Nasal & Mouth Breathing Mask Face mask with head straps (model number 8930, Hans Rudolph, Kansas, U.S.A)
• “Scott” Pressur VakTM II Face Mask (model number 803600, Amron Vista, California)
• “Hsiner” CPAP/VPAP silicone medium face mask with head straps (Model number 10214, HSINER, Taichung City, Taiwan)
• “Oxygen Hood” Amron Oxygen Treatment Hood. (Model number 8891, Amron, Vista, California)

100% oxygen was used. The oxygen used was not warmed or humidified

Head straps were used to secure the Hsiner and Hans Rudolph masks onto the subject’s face. The neck seal for the hood was placed around the subject’s neck outside the chamber before pressurization and the hood was secured and inflated by the subject on testing. The Scott mask was held onto the face by the subject and the subject was asked to ensure a tight seal to avoid leakage. The Scott mask was held in place without head straps to replicate the clinical practice at our institution.
A high-pressure O2 hose connects the demand valve to the oxygen O2 outlet. A high-efficiency particulate air (HEPA) filter was attached between the demand valve and mask.
To measure the intra-mask oxygen levels, a size 6 paediatric nasogastric (NG) tube was placed through a hole drilled into the side of the mask to lie in the mask dead space. For the oxygen hood, an NG tube was positioned underneath the neck seal on the right side of the subject’s face. The NG tube was connected to a sampling line leading outside the chamber. Mask O2 analysis was performed by connecting the sampling line to a Datex Ohmeda D-CU8 with a MiniTPX side stream gas analyser.
The devices were placed on the head by the participants.
The overall duration of observation was 50 mins
All participants were exposed to all the different devices. There was no washout period.
Intervention code [1] 324763 0
Not applicable
Comparator / control treatment
the comparator is the “Hsiner” CPAP/VPAP silicone medium face mask with head straps (Model number 10214, HSINER, Taichung City, Taiwan).
Control group
Active

Outcomes
Primary outcome [1] 332977 0
the intra-device oxygen levels

a size 6 paediatric nasogastric (NG) tube was placed through a hole drilled into the side of the mask to lie in the mask dead space. For the oxygen hood, an NG tube was positioned underneath the neck seal on the right side of the subject’s face. The NG tube was connected to a sampling line leading outside the chamber. Mask O2 analysis was performed by connecting the sampling line to a Datex Ohmeda D-CU8 with a MiniTPX side stream gas analyser.
Using an open-source data recording program intra-device oxygen levels, were recorded every 10 seconds over 6 minutes. The subject was asked to remain seated and not talk.
Timepoint [1] 332977 0
Each subject used four different oxygen delivery devices for 6 minutes consecutively in a randomized order. Statistical analysis was performed on the last 2 minutes of the measurements taken as this will most likely reflect the true intra-device FiO2.
Secondary outcome [1] 415398 0
Comparisons of mask leakage: -
Mask leakage was determined by calculating an average standard deviation of intra-device O2 for each mask. An assumption was made that higher standard deviation would equate to higher mask leakage. A comparison was made using this average.
Timepoint [1] 415398 0
Statistical analysis was performed on the last 2 minutes of the measurements taken as this will most likely reflect the true intra-device FiO2.
Secondary outcome [2] 416492 0
mask comfort
Timepoint [2] 416492 0
the subject was asked to rate the comfort of the device using a five-point Likert scale at 6 minutes
Secondary outcome [3] 416493 0
.breathability of the device
Timepoint [3] 416493 0
the subject was asked to rate the breathability of the device using a five-point Likert scale at 6 minutes

Eligibility
Key inclusion criteria
The volunteers for this study were healthy non-smoking technicians and doctors of both sexes
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
any patients
any emergency treatment

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The data for intra-device FiO2 were examined for normality using the Shapiro-Wilk test and found to be normally distributed. All data are presented as mean ± standard deviation and analysed using non-parametric tests. All P-values were two-tailed and considered statistically significant when p =0.05. Analysis of the comfortability and breathability results was found to be non-parametric using the Shapiro-Wilk test, and initial analysis was completed using the Friedman test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2020
Date of last participant enrolment
Anticipated
Actual
30/04/2022
Date of last data collection
Anticipated
Actual
30/04/2022
Sample size
Target
6
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 25092 0
New Zealand
State/province [1] 25092 0
canterbury

Funding & Sponsors
Funding source category [1] 312558 0
Government body
Name [1] 312558 0
Canterbury district hospital board
Country [1] 312558 0
New Zealand
Primary sponsor type
Individual
Name
Kenneth Lo
Address
Hyperbaric Medical Unit
2 Riccarton Avenue, Christchurch Central City, Christchurch 4710, New Zealand
Country
New Zealand
Secondary sponsor category [1] 314163 0
None
Name [1] 314163 0
Address [1] 314163 0
Country [1] 314163 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 311885 0
Ethics committee address [1] 311885 0
Ethics committee country [1] 311885 0
Date submitted for ethics approval [1] 311885 0
Approval date [1] 311885 0
Ethics approval number [1] 311885 0

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

Contacts
Principal investigator
Name 122722 0
Dr Kenneth Lo
Address 122722 0
Alfred health, 55 Commercial Rd, Melbourne VIC 3004
Country 122722 0
Australia
Phone 122722 0
+61 426612514
Fax 122722 0
Email 122722 0
Kenneth.lo@doctors.org.uk
Contact person for public queries
Name 122723 0
Kenneth Lo
Address 122723 0
Alfred Health, 55 Commercial Rd, Melbourne VIC 3004
Country 122723 0
Australia
Phone 122723 0
+61 426612514
Fax 122723 0
Email 122723 0
Kenneth.lo@doctors.org.uk
Contact person for scientific queries
Name 122724 0
Kenneth Lo
Address 122724 0
Alfred Health, 55 Commercial Rd, Melbourne VIC 3004
Country 122724 0
Australia
Phone 122724 0
+61 426612514
Fax 122724 0
Email 122724 0
Kenneth.lo@doctors.org.uk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data of primary and secondary outcomes only
When will data be available (start and end dates)?
from 1/1/2022 till 1/3/2023
Available to whom?
individuals and organisations
Available for what types of analyses?
statistical analysis
How or where can data be obtained?
contact via email: - Ke.lo@alfred.org.au


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.