Device for Aid in Neonatal and Infant Resuscitation

Report
NeO2Inspire
This project and the respective study were
supported by Laerdal Global Health and
Jhpiego, both Johns Hopkins University
affiliates. However, there are no conflicts of
interest as the project is part of the Johns
Hopkins’s Center for Bioengineering
Innovation and Design (CBID) program.
NeO2Inspire
Angelo Cruz
Brian Gu
Malvi Hemani
Barbara Kim
Taylor Lam
Dr. Soumyadipta Acharya
Dr. Robert Allen
Dr. Utpal Bhalala
Clinical Definition
“Birth asphyxia [is] defined as the failure
to establish breathing at birth.”
- WHO Bulletin on Birth Asphyxia
• Approximately 1
million deaths annually
due to birth asphyxia
• 99% deaths occur in
low-resource areas
NeO2Inspire’s Mission
To improve the outcome of neonatal &
infant resuscitation in developing
countries by providing a simple and
cost-effective technology to assist with
healthcare worker performance.
Current Standard of Care
Performed by
skilled birth
attendants (SBAs)
Current Standard of Care
Ventilation Procedure
Watch chest rise
Assess tone and color
- Warm and dry
- Stimulate
- Suction
- Check heart rate
- Monitor the
Golden Minute
40 breaths/min
Place mask properly
Apply pressure
Assess air leak
Open airway
Current Errors in Workflow
• Incorrect placement
of towel as shoulder
raise to open airway
• Mask seal not
established properly
• Failure to reroll the
towel for patent
airway due to lack of
feedback
Clinical Problem
In the hands of SBAs,
failure to open the airway
is documented as one of
the main causes for failed
resuscitation.
Insufficient
training
[1] Wall SN, et all. Int J Gynaecol Obstet. 2009.
[2] Safar P, et all. J Appl Physiol. 1959.
[3] Safar P. JAMA. 1958.
Lack of operator
feedback
Complexity of
procedure
Our Proposed Solution
Goals
Constraints
Create patent
airway
Operable by
one person
Reduce time
spent on
opening the
airway
Able to
withstand
current
standard of
disinfection
procedure
Less than $5
(affordable)
Lightweight, so
easily portable
in purse or bag
Our proposed
device
Airway Manipulation
Hyper-extension
Open Airway
Flexion (Under-extension)
Head-Tilt Angle Study
Hyper-extension
Open Airway
Flexion (Under-extension)
No previous
data to define
angle for these
positions.
Performed retrospective MRI study to
validate and define the head-tilt angle
required for airway patency in neonates
and infants (0-12 months of age).
Head-Tilt Angle Study
3
1
angle
2
• Head-tilt angle was measured as the angle between occipito-ophisthion line
and ophisthion-C7 spinous process line.
• Three measures were used to quantify airway patency:
1) Antero-posterior (AP) diameter of the airway at the level of palate
2) Antero-posterior (AP) diameter of the airway at the tongue level
3) Lateral diameter of the airway at tongue level
Findings from Head-Tilt Study
66 neonates and 17 infants:
• Closed airway can be due to either flexion or hyper-extension
• Angle for airway patency is similar for neonates and infants
• Validated that device can pertain to children 0-12 months
• No correlation between mean head-tilt angle and either
gestational age or weight of the child
• Validated that device can pertain to all children 0-12
months regardless of prematurity and weight
Open Airway: 121.90 ± 11.18*
*Associated with open airway in spontaneously breathing,
sedated neonates and infants
Flexion Closed Airway:
136.88 ± 7.32
Hyper-Extended Closed Airway:
101.73 ± 8.31
Our Solution
Our proposed solution attempts to address points of
difficulty in the neonatal resuscitation protocol.
Airway Mat
Hospitals / Health Centers
Box Mat
Home Births
Airway Mat
Box Mat
Setting: Primary and
Secondary Hospital
Settings, Community
Health Centers
•
•
•
•
•
Cost: $1.71
Angled at 121.9 degrees to ensure airway patency
Applicable for both neonates and infants
(0-12 months of age)
Reduces required training
Smooth addition to current workflow
Airway Mat
Box Mat
Setting: Home
Births, Community
Center Clinics
•
•
•
•
Cost: $2.40
Same features as airway mat
“Box” aspect allows for easy portability
Enough storage room inside box for resuscitation tools
(suction penguin, heating pads, BVM)
Future Work
IRB-approved human study to validate usage of
device on neonates and infants.
IRB-approved field study to validate clinical
application of device in community centers and
hospitals in developing countries.
Develop Manufacturing Protocol
Acknowledgements
Undergraduate Members
Sponsors and Mentors
Priya Arunachalam
Taylor Lam
Dr. Utpal Bhalala
Alisa Brown
Karina Munoz
Dr. Soumyadipta Acharya
Steven Chen
Christopher Petrillo
Dr. Robert Allen
Divya Gutala
Josh Punnoose
Kristy Peterson
Grant Kitchen
Meehir Shah
Helge Myklebust
Christine Yu
Sunny Chen
Sheena Currie
Dr. Kusum Thapa
Funding Sources
Medical Educational Perspectives – $500.00
Jhpiego – Travel Grants
Laerdal Global Health – $200.00
CBID – $1,500.00
Questions?
APPENDIX
Questions?
References
[1] Wall SN, Lee AC, Niermeyer S, English M, Keenan WJ, Carlo W,
Bhutta ZA, Bang A, Narayanan I, Ariawan I, Lawn JE. Neonatal
resuscitation in low-resource settings: what, who, and how to
overcome challenges to scale up? Int J Gynaecol Obstet.
2009;107:S47-62.
[2] Safar P, Escarraga LA, Chang F. Upper airway obstruction in the
unconscious patient. J Appl Physiol 1959; 14(5):760-764.
[3] Safar P. Ventilatory efficacy of mouth-to-mouth artificial
respiration. Airway obstruction during manual and mouth-to-mouth
artificial respiration. JAMA 1958; 167 (3): 335-341.
Airway Mat Price Breakdown
Purpose
Material
Cost/Device*
Rigid plastic
Polypropylene
$1.50
Padding
TPE Mat
$0.21
TOTAL
* Assuming that 10,000 devices are manufactured
$1.71
Box Mat Price Breakdown
Purpose
Material
Cost/Device*
Rigid plastic
Polypropylene
$2.00
Padding
TPE Mat
$0.21
Corners
Screws/Corner
Attachments
$0.19
TOTAL
* Assuming that 10,000 devices are manufactured
$2.40

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