The Upright Bag-Mask is an ergonomically-designed
reusable bag-mask intended for use in developing countries. Midwives and health
care professionals can use the Upright to ventilate newborns and babies who
need help breathing. The improved design of the mask and upright stance of the bag intend to
make it easier to obtain mask seal and provide effective ventilations during a
Upright is reusable in order to facilitate use in developing countries, where
the per-use cost of medical devices is of utmost importance. Compared to
current bag-masks, the Upright has fewer parts, making it easier to clean and
disinfect. It is designed to undergo high-level disinfection in
resource-limited settings so that it is safe for reuse. Other improvements
include a collapsible bag design for storage and transport.
A study on a newborn simulator from Tanzania and
Norway showed that students preferred using the Upright compared to a standard
bag, and ventilations with Upright had less mask leak and more delivered tidal
volume. This product complements the training program Helping Babies Breathe,
now implemented in over 70 countries. In a Tanzanian study, Helping Babies
Breathe reduced early neonatal mortality by 47% (Msemo et al).
Collapsible UprightThe collapsible Upright bag makes it easier to storage and transport.
Upright Bag-Mask in the HBB Training Setting
Upright in the hospital setting
Teamwork training using Upright
Upright's Directions for Use (DFU)The DFU is presented in a poster format so that health care workers can hang it on the wall as a quick reminder. It shows disassembly and reassembly, as well as cleaning, disinfection, and testing before use procedures.
Why Neonatal Resuscitation?
The first breath a newborn takes is the most important one in his or her life.
Every second that breathing is delayed can result in brain and organ damage
that can have long term effects.
asphyxia, a condition resulting from oxygen deprivation, is one of the top
three killers of newborns globally. One in ten babies needs help to start
breathing. About 90% of these babies can be saved through basic interventions
such as stimulation and bag-mask ventilation. Bag-mask
ventilation, while one of the most important and life-saving techniques for
resuscitating a newborn, is also one of the most challenging techniques for
health providers to perform successfully.
Almost all of the world's neonatal deaths (99%) take
place in low-income countries (WHO). In these countries in particular, many
birth attendants need training and access to effective and affordable
During bag-mask ventilation, the midwives and
healthcare workers' primary goal is to deliver air to the baby to help the baby
initiate spontaneous breathing and to prevent brain damage. By enabling the
health care worker to achieve a better mask seal with an improved ergonomic
mask design, the health care worker should be able to more successfully
ventilate the newborn and therefore decrease both neonatal morbidity and
The bag-mask concept was first created in 1953 by
Holger Hesse and Henning Ruben. Since that time, there have been very few
changes to the bag-mask, and therefore it is a significant design achievement
to create a bag that can be accepted into such an old and well established
While there are already several neonatal bag-mask resuscitators available on the market, the Upright was designed to meet additional user needs. Research has shown that with available bag-masks, facemask leakage varied from 24% to 59% among users, which means that only about half of the intended air was being delivered into the baby's airways (Schilleman et al, 2013 & Schmolzer et al, 2011). The traditional design can be counterproductive to
ventilations as the weight of one's hand can tilt the bag-mask downwards,
leading to increased leakage. It was decided to redesign the bag-mask as
vertical with an improved mask to address this challenge.
Other reusable bag-masks on the market contain nine to
twelve parts. With every added part, users are more likely to made mistakes
during disassembly and reassembly procedures. Some of these assembly mistakes
can lead to poor patient outcomes. Decreasing the number of components also
makes it faster to reassemble. Therefore, it was critical in our design that
the Upright be not only easy to take apart, but contain very clear instructions
for how to reassemble it and test its functionality.
An existing problem in the market is that masks can
fall out of the bag during a resuscitation, taking away essential time that
should be used to help the baby breathe. To address this challenge, we have
developed a new mask snap component that makes the mask easier to install and
ensures that the mask is in place and will not slip out during use.
An influential design challenge was to create an
affordable bag with uncompromised quality.
Other reusable resuscitators on the market cost anywhere from sixty
dollars to over two hundred dollars. In our design, we wanted to make sure the
product was durable and long-lasting but costing customers under twenty
Our goal was to develop an improved newborn bag-mask
that health care workers in developing countries could use to improve facemask
seal to deliver better inflations to the baby. The Upright has several benefits
that set it apart.
Improved Mask Seal: The
Upright is a newly designed approach to the bag-mask, which has existed for
decades. Some independent studies that are close to publication indicate that the
upright stance enhances the health care provider's ability to maintain a seal
between the improved facemask and the baby's face. The mask is more tolerant to
various mask grips that providers use during resuscitation.
Easily Cleaned: Upright
does not require any electricity or automated equipment for its use or its reprocessing
between uses, which makes it suitable for resource-limited settings. The
product can be high-level disinfected by boiling, with chemical agents such as glutaraldehyde,
or by steam autoclaving. The fact that the Upright can be disinfected through
boiling is novel because boiling is a much more accessible method of
disinfection in resource-limited settings than other forms of disinfection and
Fewer Components: This
product was designed with only seven parts including the mask, in order to
improve the speed and ease of reprocessing between uses. Healthcare workers and
technicians responsible for disinfecting the bag-mask and testing it for its next
use will benefit from the Upright having fewer parts.
Upright bag collapses so that it is easy to store and carry by a heath care worker.
Human Centered: Throughout the development process, health
workers and experts in low-resource countries have tested the product and its
Directions for Use on manikins. Changes to the prototypes were made based on
clinician feedback. Laerdal Global Health collaborated with a pediatrician who
tested Upright with users on a manikin before the Upright was made ready for
Programmatic Roll-out: The Upright complements the American Academy
of Pediatrics' training program Helping Babies Breathe which is now implemented
in over 70 countries.
Environmental Footprint: At Laerdal we are committed to reducing our
global footprint. As a result, all of the materials in the Upright are reusable.
The Upright does not have an expiration date but the product is expected to last
at least three years with frequent use.
The Intent & the Impact
Neonatal resuscitation have been a
particularly important focus of the global efforts to achieve UN Millennium
Development Goal 4, the reduction of child mortality. At Laerdal Global Health,
we believe in a world where no mothers or their babies should die or become
disabled from preventable causes. Our metric for success is the number of lives
saved. Neonatal asphyxia accounts for almost a third of newborn deaths, but
with confident trained providers and the right tools, it has been demonstrated
that many of these lives can be saved.
A research study is currently underway
in Tanzania randomizing the use of the Upright with a predicate bag-mask. Two
separate studies have shown that students performed significantly better with
the Upright bag-mask compared to a standard bag-mask. The mean mask leakage in
one study decreased by 9% in a group of 83 students who had no knowledge of
neonatal resuscitation. The majority of students also preferred the Upright
bag-mask compared to other models.
In the design of this product, we
consulted and collaborated with health care workers and neonatal and
resuscitation experts all over the world. Tore Lærdal, CEO of LGH, has often
been an instructor during Helping Babies Breathe courses, and his experience
with how difficult it was to explain the disassembly and reassembly of current
bag-masks was an important starting point for this project.
During the design process of the
Upright, we were able to rely upon the technical expertise and ISO quality
system of our sister company, Laerdal Medical, who has been developing bag-mask
resuscitators for many years. Therefore, during our design process we ensured
that the Upright components would be fully compatible with the Laerdal Silicone
Resuscitator's components, so that if someone mixed up components there would
never be unsafe consequences.
was developed specifically to complement Helping Babies Breathe (HBB), a
neonatal resuscitation training program that was developed by the American
Academy of Pediatrics. With the launch of HBB in 2010, the Helping Babies
Breathe Global Development Alliance was formed to support an effective and
widespread implementation of HBB. Laerdal Global Health is a founding partner
in this alliance. Thanks to this alliance, more than 250,000 birth attendants
have been trained and equipped in over 70 countries, and the intention is to
scale that up to over a million birth attendants in the next few years. The
Upright will be a key component to the future success of this program and
decreasing birth asphyxia related deaths around the world.
Answers to a real need
This one answers to a real need in a field in which, as far as we can tell, there are not many other innovations out there.