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Use of improved tools for measuring respiratory rate and oxygen saturation among community health workers : Sub-Saharan Africa and Southeast Asia.

Accuracy, usability and acceptability of respiratory rate timers and pulse oximeters when used by community health workers and first level health facility workers to detect the signs of pneumonia in children under five in resource poor settings, as compared to a medical professional counting respiratory rate or using the same pulse oximeter.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000348550
Enrollment
1730
Registered
2015-04-16
Start date
2015-03-23
Completion date
2016-01-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project, aims to evaluate the use of various respiratory rate timing and classification devices, as well as pulse oximetry devices among CHWs and FLHFWs with different levels of training in Cambodia, Ethiopia, South Sudan and Uganda. Malaria Consortium has selected these four countries due to the high proportion of under-five deaths cause by pneumonia in each of these. In addition, Ministries of Health in all four are implementing programmes where pneumonia is diagnosed and treated at community level; although their CHW programmes differ substantially across key areas such as length of training, CHW literacy level and devices used to count respiratory rates. The project will systematically review the landscape for existing tools and devices which are appropriate for low-resource settings; identify the most promising and appropriate devices for field testing; establish their accuracy in supporting the diagnosis of pneumonia symptoms or measuring oxygen levels in the blood when used by community health workers and first level health facility workers and finally, explore their acceptability and usability as perceived by community health workers, first level health facility workers and caregivers.

Interventions

The intervention aims is to identify the most accurate, acceptable, scalable and user-friendly respiratory rate (RR) timers and pulse oximeters (POx) for the detection of pneumonia symptoms by CHWs and FLHFWs in four low-income countries - Cambodia in Southeast Asia and Ethiopia, South Sudan and Uganda in Sub-Saharan Africa. The accuracy of each device in the hands of CHWs and FLHFWs will be evaluated against three reference standards: medical expert counting (to be referred to as expert counte

The intervention aims is to identify the most accurate, acceptable, scalable and user-friendly respiratory rate (RR) timers and pulse oximeters (POx) for the detection of pneumonia symptoms by CHWs and FLHFWs in four low-income countries - Cambodia in Southeast Asia and Ethiopia, South Sudan and Uganda in Sub-Saharan Africa. The accuracy of each device in the hands of CHWs and FLHFWs will be evaluated against three reference standards: medical expert counting (to be referred to as expert counter), a sample of videos of the CHW using the new devices which will be reviewed by a panel of experts and thirdly, an automated monitoring device (Masimo’s Radical-7 device) to obtain RR and oxygen saturation (%SpO2), respectively. A total of up to six new devices will be tested in this way on a sample of up to 300 children in each of the four countries. To explore the acceptability and usability of the RR counting devices and pulse oximeter devices as perceived by parents, community and FLHFWs in Sub-Saharan Africa and South-East Asia a selection of up to two RR timing/classification devices and one POx device based on minimal clinical performance standards and pile sorting with CHWs and FLHFWs. This will include an evaluation of user perceptions of the devices in routine practice. Conduct qualitative interviews with CHWs and caregivers of children under five on their perceptions and opinions regarding the device(s) used and perform intermittent quality assurance to establish whether healthcare providers’ use of the selected device remains in accordance with the training and is not changing over time. The nine devices being tested in the study can be grouped into broad device categories as follows: 1. Respiratory Rate Counters - 4 devices a) Non-automated devices include tools that support the manual counting of chest movements, by indicating when to start and stop counting and in this study the UNICEF ARI timer and counting beads are the two devices being tested. b) Automated devices support an assisted count, by automating or negating the need for manual counting of each chest movement. Mobile software applications in the category of assisted count work when CHWs tap the screen or press buttons for each chest movement. Mobile phone applications being tested in this study include a simple feature phone app called the respirometer and a SMART phone app called rrate. 2. Pulse Oximeters - 5 devices a) Handheld Pulse Oximeters tend to be more expensive than Fingertip Pulse Oximeters and are designed for professional rather than for home use. Many of them are suitable for adults, children and young infants, since oxygen is measured using a finger external sensor that can be purchased separately for paediatric and neonatal use. As with fingertip Pulse Oximeters, handheld oximeters show values of SpO2 and pulse rate in different colours on the display, but, in general, they would need additional training of CHWs because they are more complex to operate. In this study two devices will be tested - Lifebox and UTECH. b) Mobile phone applications In order to measure oxygen saturation in blood through a mobile phone application it is necessary, in addition to a smartphone or iPhone, to also have an external finger sensor. Most of these applications can be downloaded for free; however the price of the phone and the sensor has to be also included when thinking on this approach. Oxygen values of the patient are shown on the display of the phone. In this study one device will be tested - Masimo iSPO2 android pulse oximeter. c) Fingertip Pulse Oximeters are the most affordable option for measuring oxygen saturation (SpO2) in blood, and almost all of them show values of pulse rate in addition to the SpO2. A selection of fingertip pulse oximeters suitable to be use with children and showing display values in blue and black was conducted. A limitation found within this category is that some of the fingertip pulse oximeters designed for paediatric use have a limited age range of 2 to 13 years old or 15 kg weight and they are therefore not suitable for use with neonates. In this study two devices will be tested - Contec and Devon. Pairs of devices will be tested and therefore each pair of devices will be tested over a two week period in each country to achieve the required sample size.

Sponsors

Malaria Consortium
Lead SponsorCharities/Societies/Foundations

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
0 to 59 Months
Healthy volunteers
No

Inclusion criteria

A child who fulfils ALL of the following eligibility criteria will be included in this study: 1. Age between 2 months to 59 months 2. Cough or Difficulty in Breathing 3. Caregiver consent. A young infant who fulfils the following eligibility criteria will be included in this study: 1. Age 0 days to 60 days 2. Caregiver consent.

Exclusion criteria

A child with the following criteria will be excluded from this study: 1. Presenting illness of greater than two weeks duration 2. The child having severe dehydration, child with agitation/inconsolable, neck stiffness, active convulsions/fits, unconscious/lethargic, not breastfeeding and vomiting everything 3. Caregiver’s age less than 18 years 4. No Caregiver consent. A young infant with the following criteria will be excluded from this study: 1. The child having severe dehydration, child with agitation/inconsolable, neck stiffness, active convulsions/fits, unconscious/lethargic, not breastfeeding and vomiting everything 2. Caregiver’s age less than 18 years 3. No Caregiver consent.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 5, 2026