None listed
Conditions
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.
Interventions
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 satura
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.
Sponsors
Mbarara University of Science and Technology
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
2 Months to 5 Years
Healthy volunteers
No
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
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.
Outcome results
None listed