Embed Size (px)
Citation preview
New Improved Newborn Resuscitator Frode Liland, Karoline M. Linde, Jennifer Gilbertson
Laerdal Global Health, Norway
EXECUTIVE SUMMARY
Need
• One in 10 newborns need assistance to initiate breathing after birth.1
• Mortality increases by 16% for every 30 second delay in achieving effective ventilation of the baby.2
• Creating a good mask seal is a difficult skill. Two studies found median facemask leak with preterm infants at birth of 29% (16-63%)3 and 40% (0-92%)4. • In low-resource settings, manual bag-mask-valve resuscitators are typically used. These need to be reusable, low-cost, and easy to use and reprocess (disassembly, cleaning and disinfection, re-assembly and function testing)5. • It has been reported from rural hospitals in Kenya that even trained staff fail to consistently disassemble devices before disinfection, and devices frequently were overexposed to chemical disinfectants.6
• Positive End-Expiratory Pressure (PEEP) is recommended for preterm babies7.
P: +47 91106093
PRODUCT QUALITIES
BACKGROUND
A new resuscitator and facemask for newborns has been designed specifically to make newborn ventilation easier and more effective. It is designed for sustainability in low-resource settings, by being reusable and by achieving high-level disinfection with locally available methods.
With fewer parts, reprocessing is easier. One version includes a novel PEEP valve.
Challenges with current newborn resuscitators and facemasks
• Face-masks are typically soft and are difficult to seal around the nose and mouth of patients.• It is difficult to achieve effective initial ventilations with standard newborn resuscitators.11
• Existing newborn resuscitators have inherited design from adult resuscitators, including features not required for newborns, and are therefore more costly to manufacture and more complicated to reprocess.• Reprocessing instructions are integrated into instruction booklets, which are less likely to be read at a reprocessing station.• Rural hospitals in low-resource settings are less likely to have advanced reprocessing equipment (i.e. steam autoclaves), and need to use other methods of disinfection.• Few reusable PEEP valves exist in the marketplace.
Better mask sealingA manikin study with inexperienced nursing and medical students found that the new resuscitator and facemask provided significantly less mask leakage (46% vs 60%, p<0.001) than the traditional design.8
More effective ventilationsIn a randomized clinical study, the new design was compared to a tradi-tional horizontal-oriented resuscitator. The facemask was kept the new design for both resuscitator types. The new design showed higher mean expiratory tidal volume (10.0 ml/kg vs 8.6 ml/kg), higher early expired CO2 at 20 seconds (median 4.2% vs 3.2%, p=0.0099) and improved cli-nical outcome 30 minutes after delivery in 57% vs 44% of cases, but simi-lar outcome at 24 hours. After the trial, 37 of 46 responding users stated that they preferred the new vertical design.9
Improved usabilityA study from Seattle compared the new device with a traditional design. Thirty-eight participants ranging from neonatologists to midwifery students used the two designs with a manikin and test lung, and afterwards perfor-med disassembly and reassembly steps. Users then rated the devices on a Likert-scale, and results were calculated with a paired-sample t test. The new design was rated significantly better (p<.05) by the participants on apparent durability, ease of holding mask, ease of use (general), ease of di-sassembly and ease of assembly, but significantly less on ability to observe chest rise.10
Sustainable for low-resource settings
Disinfection• Steam-autoclavable, but is also validated for high-level disinfection with methods which may be the only available methods in low-resource settings: Boiling in clean water, or immersion in activated glutaraldehyde.
Durability • Constructed with only durable materials (silicone rubber, polysulphone plastics, stainless steel), and is tested for 100 cycles of each reprocessing method.• Spare parts of valve components and masks are available.
Usability in reprocessing• Designed with as few components as possible, so as to reduce complexity in reprocessing. (New device: 7 components for the user to handle. Traditional devices: 8 to 13 components).• Complete reprocessing instructions are designed as an A3-size poster that can be hung on the wall.
Reusable PEEP ValvePositive end-expiratory pressure (PEEP) retains a volume of air in the lungs between each ventilation. For newborns with fluid-filled or immature lungs, PEEP helps prevent repeated lung alveolar collapse during ventilation. This helps recruit lung volume more efficiently, clear fluid from the lungs and reduces damage to the lung tissue.
Use of PEEP with newborns that require resuscitation is the stan-dard-of-care in resource-rich environements using T-piece resuscita-tors.
Bag volume is increased to 330 ml (from typically 230 ml), which allows more air to be available to the baby when there are leakages.High-visibility label shows
complete disassembly of device for reprocessing.
New facemask design, provided in Sizes 0 and 1, has a thicker and broader top surface less
likely to be deformed by user’s mask-holding technique and
cause mask leakage.
Meets international standards (ISO 10651-4)
and is CE-marked.
1 Save the Children - State of the World’s Mothers 2013.2 Ersdal HL: Early initiation of basic resuscitation interventions including face mask ventilation may reduce birth asphyxia related mortality in low-income countries: A prospective descriptive observational study. Resuscitation 83 (2012) 869-8733 Schmölzer GM: Assessment of tidal volume and gas leak during mask ventilation of preterm infants in the delivery room. Arch Dis Child Fetal Neonatal Ed 2010 95: F393-F397.4 Schilleman K: Evaluating Manual Inlfations and Breeathing during Mask Ventilation in Preterm Infants at Birth. The Journal of Pediatrics 2013 Vol. 162, No. 3: 457-4635 PATH. Reprocessing Guidelines for Basic Neonatal Resuscitation Equipment in Resource-Limited Settings. Seattle: PATH; 2016.6 Eslami P: Letter to Editor - Improper Reprocessing of Neonatal Resuscitation Equipment in rural Kenya compromises functio: Recommendation for more effective implementation of Helping Babies Breathe. Resuscitation 91 (2015) e5-e6
Attachment for accessory oxygen kit
Pressure relief valve releases air if airway pressure
exceeds 30-45 cmH2O
Pull-tab eases disassembly of bag from inlet valve
housing
Improved ergonomic position with the vertical-oriented resuscitator, with mass of
device centered directly over facemask.
References:
3.Testing before use
Squeeze the bag. Check that the yellow valveopens and closes with every squeeze.
Keep the mask sealed against your hand. Release the squeezed bag. Check that the bag re-expands without resistance.
Keep the mask sealed against your hand. Press the pressure release valve down. Squeeze the bag and check that there is no leakage.
Seal the mask against your hand. Squeeze the bag forcefully. Check that air is released from the pressure release valve.
If any of the above tests fail: Dismantle device, inspect the components, reassemble device and repeat the complete “Testing before use” procedure (Section 3).
60 minutes10 minutes100 °C Disinfect
Always dismantlebefore cleaning
1
2
3
4
Wash all parts in aclean tray with clean water and mild soap.
Use a scrub or brushto remove any soil.
Rinse parts in cleanwater to remove all soil and soap.
Repeat above stepsuntil parts are clean.
Dry all parts.
Visually inspect each part for damage andcleanliness /mineral deposits.
Remove damagedor unclean parts from service.
Reassemble.
Test usings stepsshown below.
OR OR
2. Cleaning and Disinfection procedure
1. Product overview
1. Dismantle 2. Clean 3. Disinfect by one of the methods 4. Dry and Inspect 5. Assemble and Test
1 2 3 5 6
Pull Out Unscrew Lift Out UnscrewPull Out
To dismantle, follow steps 1- 6. To reassemble, follow the steps in reverse.
Do not disassemble parts beyond the steps shown.
4vPull forcefully on tab to release
Chemical
Activated glutaraldehyde solution:
1
2
3
4
Autoclaving
Sterilize by steam autoclaving at 136 °C and 2.0 kg/cm2 for 10-20 min.
Boiling*
Boil all parts in clean water for 10 min.
10-20 minutesSteam 136 °C
Reprocessing instructions
Page 2
Disinfect all parts to the dis-infectant manufacturer’s recommended procedure.
Immerse for 60 minutes.
Remove parts using aseptic technique.
Rinse 3 times, for 1 minute using fresh clean water each time.
1
2
3
1. Lip valve function 2. Inlet valve opening 4. Product sealing3. Pressure release valve
+ rinsein water
3 x 1 minute
*Validated at approximately sea-level pressure
Check that the silicone bag's lip is not twisted or tucked under.
4
A version of the improved resuscitator is designed with a reusable PEEP valve with a fixed PEEP setting of 6 cmH2O, reducing risk of user errors.
A manikin study showed that inexperienced users were able to achieve PEEP of 4-5 cmH2O, even though mask leakage was 48-58%.12
The improved resuscitator with the PEEP valve has 9 components in to-tal for the user to handle in reprocessing. An alternative available product combination in the market has 19 components.
7 ILCOR. 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation 2015;95:e1-e261.8 Thallinger M: Randomised comparison of two neonatal resuscitation bags in manikin ventilation. Arch Dis Child Fetal Neonatal Ed 2016;101:F299-F3039 Thallinger M: Born not breathing: A randomised trial comparing two self-inflating bag-masks during newborn resuscitation in Tanzania. Resuscitation 2017: Article in press10 Coffey PS: Performance and Acceptability of Two Self-Inflating Bag-Mask NeoNatal Resuscitator Designs. Respiratory Care. September 2015 Vol 60 No9: 1227-123711 Milner AD: Efficacy of facemask resuscitation at birth. British Medical Journal. Volume 289, 8 December 1984.12 Thallinger M: Neonatal ventilation with a manikin model and two novel PEEP valves without an external gas source. Arch Dis Child Fetal Neonatal Ed 2016;0:F1-F6
New mask is easier to insert and has snap connection to the new resuscitator, prevent accidental mask disconnecting.
PEEP valve PEEP valve
