Airway Shield™ Detailed Product Guide: Origin, Use and Scientific Studies
Airway Shield™ Detailed Product Guide: Origin, Use and Scientific Studies
This page is intended for healthcare professionals. Read the instructions for use (IFU) before using the product.
Manufacturer and origin
- Manufacturer: Airway Shield, S.L. (Spain)
- Founded: In 2020 in Santander, Spain. The company has offices in Madrid and Santander.
- Founder: Dr. Julio Alonso Babarro, a specialist in intensive care medicine. The idea for the device grew out of experience with difficult intubation in prehospital emergency settings and the exposure of clinicians to aerosols during the COVID-19 pandemic.
- Support: The project has been supported by the NEOTEC program of CDTI, Spain's public technology and innovation agency, and by SODERCAN, the regional development agency of Cantabria.
- Manufacturing: The company outsources production to regional manufacturing partners, which, according to the company, are located in Australia and Taiwan.
- Regulatory status: According to the company, the device received the CE mark in 2022. In the United States, the FDA granted the device "Safer Technologies Program (STeP)" designation in 2022. This designation is not a marketing authorization but a program that accelerates development and review.
- Türkiye: Prizma Med Sağlık Hizmetleri is the exclusive Türkiye distributor for Airway Shield™.
What is the device?
Airway Shield™ is a single-use mouthpiece and guide placed in the patient's mouth during endotracheal intubation. It is made of soft, medical-grade thermoplastic elastomer (TPE) and combines three functions in one piece:
- Guiding channel: Its semi-rigid structure directs the endotracheal tube toward the vocal cords, in the direction indicated by the laryngoscope blade.
- Dental protection: Its reinforced area is designed to reduce pressure on the upper incisors during laryngoscopy.
- Barrier: The protective shield covers the patient's mouth. The sealed central opening allows passage of the laryngoscope and tube while limiting the spread of aerosols and droplets. Suction can be performed during the procedure through two sealed lateral openings.
Application workflow
- The patient is positioned and preoxygenated in the standard way.
- Airway Shield™ is placed in the patient's mouth; the shield covers the mouth.
- The laryngoscope blade is advanced through the central opening and the glottis is visualized.
- The endotracheal tube is advanced along the guiding channel and passed through the vocal cords.
- If needed, secretions are suctioned through the lateral openings.
- After tube placement is confirmed, the device is removed.
Refer to the product's instructions for use for detailed steps and warnings. The manufacturer offers a training app for learning the technique. The Prizma-Med team can provide hands-on training at your institution.
Scientific studies
Airway Shield™ is a new device, and its evidence is still mainly based on preclinical studies. Below we summarize the published and presented studies together with their level of evidence.
1. Manikin study (published in a peer-reviewed journal)
Alonso J, Lipman J, Shekar K. A novel barrier device and method for protection against airborne pathogens during endotracheal intubation. European Journal of Anaesthesiology 2022;39(11):900-903.
- Setting and method: 8 simulated intubations performed by a single operator on two different high-fidelity manikin models in Brisbane, Australia. Scenarios: intubation during cardiopulmonary resuscitation and intubation during preoxygenation with high-flow nasal cannula.
- Finding: The amount of aerosol and droplets released into the environment (pixel count measured by photographic analysis) averaged 509 with the device and 10,169 without it (p=0.014), corresponding to a reduction of approximately 95%. First-pass intubation was achieved in all scenarios.
- Limitation: This is a small pilot study performed on manikins, not patients. The authors state that clinical trials are needed.
2. Congress presentations
- ESICM LIVES 2021: Presentation on the protective barrier properties of the device (Intensive Care Medicine Experimental, 2021, abstract 000641).
- Euroanaesthesia 2025: Pilot clinical study evaluating the safety of intubation with the device in elective surgical patients.
- Guy's Hospital Airway Management Course: Study on the learning curve of the technique.
- WAMM 2025 (Florence): Study on the device's potential to reduce trauma risk during intubation.
We will update this page when the full results of the clinical studies are published in peer-reviewed journals.
Data shared by the manufacturer
The manufacturer reports a reduction of up to 50% in intubation time in preclinical studies. This has not yet been supported by patient outcomes in a peer-reviewed publication; please take this into account in your evaluation.
Where can it be considered?
- Anesthesia and the operating room: elective and emergency intubations
- Intensive care: intubation of critically ill patients, patients with suspected respiratory infection
- Emergency departments and prehospital emergency care: intubation in constrained conditions
- Patients with fragile teeth or dental prostheses (for dental protection)
Demo and training requests
For clinical evaluation, samples and hands-on training: Phone +90 342 360 64 50 · WhatsApp +90 533 349 61 62 · info@prizmamed.com.tr
Sources: Alonso J, Lipman J, Shekar K. Eur J Anaesthesiol 2022;39(11):900-903 (preprint: medRxiv 2022.01.24.22269341). · airwayshield.com (Our Technology, Grants). · Capital Cell, Airway Shield 2023 campaign page. · Proxima Clinical Research press release, 18 May 2022 (FDA STeP). · Spanish National Entrepreneurship Office (ONE), interview with Julio Alonso. Origin and regulatory information is based on the manufacturer's public statements.