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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000348550
• Date of registration: 16/04/2015
• Prospective Registration: No
• Primary sponsor: Malaria Consortium
• Public title: Use of improved tools for measuring respiratory rate and oxygen saturation among community health workers : Sub-Saharan Africa and Southeast Asia.
• Scientific title: 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.
• Date of first enrolment: 23/03/2015
• Target sample size: 1720
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000348550.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Cambodia, Ethiopia, Sudan, Uganda

Contacts

• Name: Mr Kevin Baker

• Name: Mr Kevin Baker

Key inclusion & exclusion criteria

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.



Age minimum: Days
Age maximum: 59 Months
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Public Health - Health service research

Respiratory - Other respiratory disorders / diseases

Pneumonia;
Pneumonia

Intervention(s)

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) N

Primary Outcome(s)

The primary outcome for the evaluation of respiratory rate timing/classification devices will be:

The difference (or delta) in the, reading of the CHW and the continuous monitor (Masimo Radical 7)
AND
The difference (or delta) in the reading between the expert counter and the continuous monitor.
[2 months or until the required sample is reached]

For the Pulse Oximeter devices the primary outcome will be agreement in SpO2 reading between the CHW/FLHFW and the expert counter. As a back-up SpO2 comparison, the reading from the Masimo’s Radical 7, Pulse Oximeter will be used.[Two months or until the required sample size is reached]

Secondary Outcome(s)

Acceptability and usability of new devices by community health workers and first level health facility workers. This will be done using semi-structured qualitative interviews and checklists completed by research assistants as the CHWs use the devices.

[2 months or until the required sample is reached]

Acceptability of new devices to caregivers. This will be done using semi-structured qualitative interviews with caregivers after the CHWs have conducted their assessments.[Two months or until the sample size has been reached.]

Secondary ID(s)

BMGF Global Health Grant OPP1054367

Source(s) of Monetary Support

Bill and Melinda Gates Foundation

Ethics review

Status: Approved
Approval date:
Contact:

Makerere University IRB Committee

Status: Approved
Approval date:
Contact:

National Ethics Committee for Health Research (NECHR), Ministry of Health

Status: Approved
Approval date:
Contact:

South Sudan IRB, Research and Ethics committee at the Government of South Sudan

Status: Not approved
Approval date:
Contact:

Southern Nation Nationalities Peoples' Region Health bureau health research review committee