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 resuscitation.

The 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).

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.

Neonatal 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 therapeutic tools.

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 mortality.

Design Challenges

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 market.

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 dollars.

Our Solution

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 sterilization.

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.

Easy-to-Transport: The 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 sale.

Programmatic Roll-out: The Upright complements the American Academy of Pediatrics' training program Helping Babies Breathe which is now implemented in over 70 countries.

Reduced 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.

The Upright 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.