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Trial registered on ANZCTR


Registration number
ACTRN12620001304921
Ethics application status
Approved
Date submitted
22/09/2020
Date registered
2/12/2020
Date last updated
2/12/2020
Date data sharing statement initially provided
2/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Initial clinical evaluation of the FREO2 Siphon electricity-free oxygen concentrator in Bugoye Health Centre III
Scientific title
Initial clinical evaluation of the FREO2 Siphon electricity-free oxygen concentrator for use in hypoxic infants up to 5 years old in Bugoye Health Centre III
Secondary ID [1] 302314 0
None
Universal Trial Number (UTN)
U1111-1258-3046
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Hypoxaemia 319077 0
Condition category
Condition code
Respiratory 317027 317027 0 0
Other respiratory disorders / diseases
Public Health 317402 317402 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In this study the FREO2 Siphon device installed in Bugoye, Uganda, will be used to supply oxygen to paediatric patients between 2 months and 5 years of age. As a backup if the Siphon is not operational, the oxygen supply will automatically revert to a cylinder of medical oxygen. Oxygen will be supplied to the patients using a nasal canula and the flow rate controlled by an adjustable gas flow meter. The level of flow will be adjusted in the range 0 to 2 L/min in response to the oxygen saturation level as observed on a pulse oximeter. Patients will be recruited to the trial from the population of children (2 months to 5 years old) presenting to the health centre with cough or breathing difficulties who have a SpO2 of < 90% and are responsive to a trial application of oxygen. The trial application is to begin oxygen treatment at 0.5 litres per minute. Aim to use the lowest flow rate of oxygen that keeps the SpO2 at 90% or more. Maximum rate administered is 2 L/min and a patient would be classified as non-responsive if 2 L/min did not raise SpO2 to 90% or more.
Non-responsive patients will be referred to higher level health facility for treatment and will not be part of the trial. Patients will be treated for a maximum of 3 days and the intervention will be complete either when the patient does not need oxygen therapy to maintain SpO2 > 90% or referral of the patient to a higher level health facility if they do not improve. The intervention will be administered by specifically trained nurses under the remote supervision of a medical doctor. Once per day the supervising doctor will consult with the Head of the health centre to review the case notes and monitor adherence to the trial protocols.
Intervention code [1] 318605 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325131 0
The proportion of recruited patients successfully treated at the Bugoye Health Centre. The outcome will be determined by reviewing the regularly collected medical records of paediatric patients attending the health centre to determine the appropriate number of patients in 8 categories in the process from "all children presenting" to "successfully treated".
Timepoint [1] 325131 0
After 6 months from the study commencement or treatment of 24 patients; whichever occurs first.
Secondary outcome [1] 386954 0
The proportion of children presenting to the Bugoye Health Centre who had a cough or difficulty breathing and were aged 2 months to 5 years. The outcome will be determined by reviewing the regularly collected medical records of paediatric patients attending the health centre to determine the appropriate number of patients in 8 categories in the process from "all children presenting" to "successfully treated".
Timepoint [1] 386954 0
After 6 months from the study commencement or treatment of 24 patients; whichever occurs first.
Secondary outcome [2] 386955 0
The proportion of children presenting to the Bugoye Health Centre who had a cough or difficulty breathing and were aged 2 months to 5 years, who also had a SpO2 level of < 90%. The outcome will be determined by reviewing the regularly collected medical records of paediatric patients attending the health centre to determine the appropriate number of patients in 8 categories in the process from "all children presenting" to "successfully treated".
Timepoint [2] 386955 0
After 6 months from the study commencement or treatment of 24 patients; whichever occurs first.
Secondary outcome [3] 387962 0
The flow rate of oxygen to the patients. Electronic monitoring of oxygen flow rates will be used to check the flow rate recorded in patient notes of each patient.
Timepoint [3] 387962 0
For each individual patient receiving oxygen, from the point of oxygen be administered to the point when the patient is weaned or referred to another facility. This is a maximum of 3 days for any one patient.
Secondary outcome [4] 387963 0
The total amount of oxygen used for each patient. Electronic data acquisition will monitor flows in real time which are recorded approximately every 30 minutes. At the end of the trial this data will be analysed and compared to patient records of oxygen use.
Timepoint [4] 387963 0
After 6 months from the study commencement or treatment of 24 patients; whichever occurs first.
Secondary outcome [5] 388984 0
The total duration of oxygen use for each patient. Electronic data acquisition will monitor flow duration in real time which are recorded approximately every 30 minutes. At the end of the trial this data will be analysed and compared to patient records of oxygen use.
Timepoint [5] 388984 0
After 6 months from the study commencement or treatment of 24 patients; whichever occurs first.

Eligibility
Key inclusion criteria
1 Voluntarily present at the health centre
2 Have a cough or difficulty breathing
3 Age between 2 months and 5 years
4 Have SpO2 of greater than 80% and less than 90%
5 Responds favourably to an initial trial of oxygen therapy
6 Patient does not exhibit 'danger signs" indicating they should be referred to hospital
7 Parent/guardian gives informed consent
Minimum age
2 Months
Maximum age
5 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The patient has 'danger signs' that indicate they should be referred to a higher level health facility where staff with more advanced diagnostic skills and equipment are available.

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)
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
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The research questions related to the functioning of the FREO2 Siphon system itself are all estimates of single parameters (e.g. the flow rate of oxygen to patients, or the purity of oxygen produced), or of single proportions (e.g. the proportion of minutes during the study period that there is a requirement for oxygen flow outwards to patients). These research questions thus do not involve statistical hypothesis testing. Where proportions (e.g. of components failing) or times to failure are calculated appropriate confidence intervals will be calculated as though the components or time intervals were a random sample of all components or time intervals in a future system. There is thus no requirement for a specific sample size (although the automated data acquisition system records observations once per second, so the number of observations will be very high).
The clinical research questions also involve estimates of single parameters (e.g. the flow rate of oxygen to patients) or single proportions (e.g. the proportion of hypoxaemic children who have danger signs and cannot be treated safely at a Health Centre III). Again these questions do not involve statistical hypothesis testing, so the main influence of sample size is on the precision of the final estimate. There is therefore no minimum number required in order to answer these questions. For example, if we find that 75% of children can be treated successfully, to achieve a 95% confidence interval of +/-20% we would need to enrol 33 children. On the other hand, enrolling 57 children would give a confidence interval of +/- 15% for the same overall proportion of 75%. As there is little prior information about either the number of hypoxaemic children we can expect, or the proportion who can successfully be treated, this kind of exploratory study can be done without a strictly-defined sample size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22988 0
Uganda
State/province [1] 22988 0
Western Region

Funding & Sponsors
Funding source category [1] 306741 0
University
Name [1] 306741 0
The University of Melbourne
Address [1] 306741 0
Grattan Street,
Parkville, 3010 Victoria
Country [1] 306741 0
Australia
Primary sponsor type
University
Name
Mbarara University of Science and Technology
Address
P.O BOX 1410,
Mbarara
Country
Uganda
Secondary sponsor category [1] 307290 0
University
Name [1] 307290 0
The University of Melbourne
Address [1] 307290 0
Grattan Street,
Parkville, 3010 Victoria
Country [1] 307290 0
Australia
Secondary sponsor category [2] 307293 0
Hospital
Name [2] 307293 0
Massachusetts General Hospital
Address [2] 307293 0
55 Fruit Street
Boston, MA 02114
Country [2] 307293 0
United States of America
Secondary sponsor category [3] 307294 0
Charities/Societies/Foundations
Name [3] 307294 0
FREO2 Foundation Australia
Address [3] 307294 0
L 2 696 Bourke St
Melbourne VIC 3000
Country [3] 307294 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306913 0
Mbarara University of Science and Technology Research Ethics Committee
Ethics committee address [1] 306913 0
Mbarara University of Science and Technology
MUST REC
P.O BOX 1410, Mbarara
Ethics committee country [1] 306913 0
Uganda
Date submitted for ethics approval [1] 306913 0
17/04/2019
Approval date [1] 306913 0
26/07/2019
Ethics approval number [1] 306913 0
17/04-19

Summary
Brief summary
FREO2 Foundation Australia, the Mbarara University of Science and Technology in Uganda, and Massachusetts General Hospital in the USA, propose a preliminary clinical investigation of the FREO2 Siphon electricity-free oxygen concentrator (developed by FREO2 Foundation Australia and FREO2 Pty Ltd), as an alternative system to supply oxygen for patients in remote areas with limited facilities for oxygen supply. In this study oxygen will be supplied to at least one designated paediatric (under-five) bed in the Bugoye Health Centre. Children presenting with cough and/or difficult breathing, or being admitted or transferred for any reason, will be assessed for hypoxia. Children between two months and five years without contraindications to oxygen therapy at Health Centre III level will be treated and their clinical outcomes assessed.
Trial website
Trial related presentations / publications
Public notes
This proposal is also registered with the Uganda National Council for Science and Technology with registration number HS 2671

Contacts
Principal investigator
Name 105426 0
Prof Edgar Mugema Mulogo
Address 105426 0
Mbarara University of Science and Technology
P.O BOX 1410, Mbarara
Country 105426 0
Uganda
Phone 105426 0
+256 772 692674
Fax 105426 0
Email 105426 0
emulogo2000@gmail.com
Contact person for public queries
Name 105427 0
Dr Bryn Sobott
Address 105427 0
Dept of Physics,
The University of Melbourne
Grattan Street
Parkville, 3010, Victoria
Country 105427 0
Australia
Phone 105427 0
+61 431 440 820
Fax 105427 0
Email 105427 0
bryn@freo2.org
Contact person for scientific queries
Name 105428 0
Dr Bryn Sobott
Address 105428 0
Dept of Physics,
The University of Melbourne
Grattan Street
Parkville, 3010, Victoria
Country 105428 0
Australia
Phone 105428 0
+61 431 440 820
Fax 105428 0
Email 105428 0
bryn@freo2.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a very small study with minimal budget. Resources for sharing and maintaining IPD have not been allocated.
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 9173 0
Study protocol
Citation [1] 9173 0
Link [1] 9173 0
Email [1] 9173 0
bryn@freo2.org
Other [1] 9173 0
Attachment [1] 9173 0
Type [2] 9174 0
Informed consent form
Citation [2] 9174 0
Link [2] 9174 0
Email [2] 9174 0
bryn@freo2.org
Other [2] 9174 0
Attachment [2] 9174 0
Summary results
No Results