Learn more about an innovative new tool that assesses respiration rate and temperature in small children to aid in the diagnosis of pneumonia in low resource settings where access to x-rays is severely limited. The recipient of grants from Grand Challenges Israel and USAID's Development Innovation Ventures, RespiDx is now testing the effectiveness of the Respimometer in the Democratic Republic of Congo.

1. RespimometerTM – for Early Diagnosis of Pneumonia
Pneumonia Innovation Team Briefing
May 2016

2. Pneumonia
 Kills about a million children under 5 every year
 Primary cause of child death in the developing world
 UNICEF & WHO lead fight against pneumonia, a huge
effort to improve diagnosis and treatment
“Timely recognition of key pneumonia symptoms by caregivers
followed by seeking appropriate care and antibiotic treatment for
bacterial pneumonia is lifesaving”.
(Pneumonia and diarrhea: Tackling the deadliest diseases for the world’s poorest children, UNICEF 2012)
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3. Diagnosis of Pneumonia
In the absence of chest radiology &
blood tests, pneumonia is classified
based on symptoms and physical
examinations -
 Tachypnea – high respiratory rate
 Fever – high body temperature
 Hypoxemia – low oxygen level
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4. Respiratory Rate Counting
 According to WHO and UNICEF, pneumonia is classified by a rapid
respiratory rate (RR) as counted by a health worker
 The diagnosis guideline for pneumonia at community level
requires that a health worker counts a sick child‘s breath during 1
minute by looking at his chest rising and falling
 ARI (Acute Respiratory Infection) Timer is a 30-sec, 1-minute
timer with an alarm
 Requirement to find a simple yet superior solution
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5. RespimometerTM
 …is shaped like a regular digital thermometer, but has two
thermistor-type sensors located in its mouth-stop
 The Respiratory Rate (RR) is measured by analyzing the
inhalation/exhalation waveform to provide rapid and
accurate diagnosis of pneumonia
 Binary sick / normal indication to be provided per child’s age
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6. Status and Grants
 Received a Grand Challenges Israel grant
 Built 10 simple models with RR algorithm
on external PC
 Performed initial testing in Democratic
Republic of the Congo (DRC)
 Together with local NGO AFHIA, managing
and oversee trials in Butembo, North Kivu
 Identified needs and main challenges
facing the product in practical use
 Recently awarded an USAID grant in order
to design, manufacture and test 200
enhanced models
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7. In the Lab In the DRC
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8. Transition to MultimometerTM
 Currently integrating a reflective pulse oximeter chip into the
front of the mouth-stop
 The product will then replaces 3 stand alone devices -
Respiratory Rate Monitor, Thermometer and Pulse Oximeter
 Provides all vital signs (except BP), enabling it to be:
 used in developing countries primarily for pneumonia diagnosis
 used in the 1st world, for home use and telemedicine
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9. DRC Team
 Dr. Claude Kasereka Masumbuko – Physician,
Université Catholique du Graben, Matanda
General Hospital, Butembo, DRC
 Dr. Michael Hawkes – Clinician Scientist,
Pediatric Infectious Diseases, University of
Alberta
 Prof. Israel Amirav, MD – Co-founder
RespiDx Ltd., Expert in Pediatric
Pulmonology, Univ. of Alberta, Edmonton,
Canada
 Participating CHWs
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11. The problem: community-based
management of pneumonia
 Target user: community health worker
 Challenge:
 integrated community-based management (iCCM) of
newborn and childhood illness requires measurement of
respiratory rate by minimally trained CHWs
 Not as easy as it sounds!
 Solution:
 The MultimometerTM solves this problem, enabling the
WHO IMCI algorithm for pneumonia management to be
applied at the village level
- Confidential - 11

12. Integrated community case
management (iCCM)

13. WHO: Classification and treatment of pneumonia

15. Study Location
 Democratic Republic of Congo (DRC) has 3rd highest number of
childhood pneumonia deaths in the world: 126,000 (after India and
Nigeria)
 North Kivu province in eastern, war-torn area
 Rural, remote, resource-limited setting
 Health care infrastructure devastated by war and ongoing insecurity
 Access to health care is challenging
 Our own group has performed several studies in this area, and we
have a longstanding and productive partnership with local NGO
Association For Health Innovation in Africa (AFHIA)
 CHWs with minimal medical or nursing training provide basic health
services (e.g., malaria diagnosis, drug distribution) to remote villages
where there is no doctor or hospital
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16. Study Design
 The study will compare MultimometerTM temperature and
respiratory rate data obtained by CHWs to gold standard
pediatrician-assessed measurements using (independent,
blind):
 axillary or rectal thermometry
 visual counting + auscultation or capnography
 The population of interest will be a prospective cohort of
infants and children with cough/difficulty breathing
presenting to the CHW in the village context
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17. Study Design (continued)
 The device performance characteristics will be assessed using Bland-
Altman plots, sensitivity, specificity, positive and negative predictive
values, and likelihood ratios for the diagnosis of fever (T>37.5C) and
tachypnea (RR>50 in infants 2mo to 1 yr; RR>40 in children 1-5 yr).
 Secondary objectives will be to examine qualitative aspects of device
design, pragmatic considerations such as instrument sterilization in
the field, and user preferences (CHW and parent)
 As the device will also be providing pulse-oximetry data, an initial
review of the potential use of this data in the field will be performed
as a confirmative indicator of the pneumonia diagnosis
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28. Next Stages
 Design-for-Manufacture stage of the device, to enable the transfer
from engineering to mass production
 Quote received from a major custom-electronics manufacturer enables
us to estimate costs for mass manufacturing
 Raising funds to deploy the devices to the 2.5 million CHWs in relevant
locations, and provide them with training
 Evaluation of impact of device on referral, pneumonia-specific
mortality: stepped-wedge cluster randomized controlled trial
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