Endotracheal Intubation of Difficult Airways in Emergency Settings: A Guide for Innovators

Figures & data

Table 1 Comparison of Existing Airway Management Solutions

Airway Management Approach	Device	Advantages	Limitations
Direct Laryngoscopy^Citation8–10,Citation36–40	Macintosh (Mac) Blade	Higher success rate and lower time for novel users (vs Miller) Direct line of sight More room for ETT insertion Less trauma than Miller blade	Dental trauma Laryngeal trauma
	Miller Blade	Higher success rate with floppy glottis or anterior airways (vs Mac) Direct line of sight	More trauma than Mac blade
Indirect Laryngoscopy^Citation2–4,Citation15–17,Citation25,Citation41–44	Channeled	Higher success in difficult airways Compared to DL: greater visualization and FSRs, less time, lower rate of esophageal intubation, less trauma Direct path for ETT insertion Permits multiple viewers	Reduced manipulation of ETT Variable learning curve Requires multiple devices Risk of video failure More expensive equipment Loss of depth perception
	Non-channeled	Easier manipulation and enhanced visualization over channeled	Difficulty handling ETT and scope
Bougie^Citation36,Citation43,Citation44		Higher FSRs than DL/IDL Can rotate 90° Small and flexible Blind intubations Confirm with tracheal ‘clicks’ Used in conjunction with IDL/DL	Risk of airway perforation tissue damage Too flexible at times= lack of shape retention Insufficient pressure by tip Difficult steerability due to flexibility
Extraglottic Devices^Citation1,Citation36,Citation40,Citation45–50	LMA	Wide variety to accommodate different airway/ETT sizes Designed for blind intubation, requires less inflation for a seal; accommodates intubation with standard ETTs High injury-free success rate	Cannot be used with severe facial trauma, restricted or distorted airways, obstructions, or stiff neck/lungs Complications including dysphagia, bronchospasm, and laryngeal injury High failure in obese patients High failure with novel physicians Not compatible with airway fluids
	i-Gel	Improved seal compared to LMA High success rates in difficult airways
Surgical Airway^Citation51,Citation52	Cricothyrotomy	Efficient for experienced physicians Minimally invasive for being an open procedure Low risk of esophageal placement	Risk of bleeding, vocal cord or airway damage, and perforation of internal membranes by blade Requires experienced physician Risk of infection and injury
	Needle	Preferred method for children Less invasive than cricothyrotomy	Risk of infection, hemorrhage, and perforation of the posterior trachea

Figure 1 (A) Market landscape analysis comparing cost and efficacy of current solutions. Qualitative efficacy was determined from a combination of reported physician importance, intubation success rates for no more than three attempts, and efficacy reports from peer-reviewed journals. Costs were determined using medical device purchasing platforms and clinical reports. Data from these studies.^{50,52,61–67} (B) Market landscape analysis comparing first-attempt success rate and cost. Note that the data used to populate first-pass success rate has studies pertaining to typical airway management as the upper bounds, and difficult airways as the lower bounds, when applicable. Data from these studies.^68–76 (C) Market landscape analysis comparing time for intubation and cost. Note that times may overlap for adjunct devices and respective devices whose insertion they assist. **Indicates device with learning curve in medical trainees as indicated by literature. Data from these studies.^{71–74,76–79,80}

Abbreviations: OPA, oropharyngeal airway; NPA, nasopharyngeal airway.

Figure 2 Airway management device patents. Only the devices indicated with an asterisk can maintain the airway independently and are thus referred to as direct devices in this report. The remainder of the devices are either adjuncts, meaning they are assistive devices for insertion, or they are unable to both maintain patency and allow for oxygenation and are used in the pre-hospital setting or before intubation. To probe the number of devices manufactured in each category, the number of active patents was ascertained. Note that the number of patents will be much greater than the number of FDA-approved devices on the market, but this information is less readily available. Data from Home. Anesthesia Airway Management (AAM). https://aam.ucsf.edu/.⁸⁶

Figure 3 Patient segmentation for airway management. Although difficult airway attributions can be further segmented, unless current technologies fail to meet the needs of a subsection of the population, over-limiting the target population will negatively impact investor opportunity. Target segments of the population are shown in blue. Data from these studies.^7,87,89

Table 2 Rational for Innovative Focus, Weighing the Pros and Cons of Key Categories of Decision-Makers to Determine the Product’s Commercial Viability to Validate the Selected Target Market. The Graphic Contains Synthesis from This Market Report, Knowledge Obtained from Previous User Interviews and Zenios et al⁹⁴

Stakeholder	Opportunity	Risk
Users	Device that decreases correlation between experience and success to be likely adopted into training^Citation9,Citation53 Device’s articulation and use can mirror existing solutions for seamless clinical integration	Interviewed providers in academic, level 1 trauma centers do not express explicit needs in intubation success and efficiency based on user experience
Investors	Substantial TAM, SAM, SOM^Citation69,Citation93 High potential for payer savings if able to successfully intubate on first-pass, increasing likelihood of reimbursement	Crowded market- without a substantial competitive advantage, ROI will be diminished due to lower-than-expected market penetration
Innovators	Motivated team with range of skills to address engineering, marketing, and clinical aspects Solutions do not need to address both software and hardware, minimizing development time Access to financial and intellectual capital	Teams with lack of prior experience in industry and healthcare Competitors may include some of the largest global manufacturers^Citation69

Baek MS, Han M, Huh JW, Lim CM, Koh Y, Hong SB. Video laryngoscopy versus direct laryngoscopy for first-attempt tracheal intubation in the general ward. Ann Intensive Care. 2018;8(1):83. doi:10.1186/s13613-018-0428-0

 PubMedGoogle Scholar

Arino JJ, Velasco JM, Gasco C, Lopez-Timoneda F. Straight blades improve visualization of the larynx while curved blades increase ease of intubation: a comparison of the Macintosh, Miller, McCoy, Belscope and Lee-Fiberview blades. Can J Anaesth. 2003;50(5):501–506. doi:10.1007/BF03021064

 PubMed Web of Science ®Google Scholar

GlideScope medical devices. Available from: https://www.verathon.com/glidescope/. Accessed June 20, 2023.

 Google Scholar

Breedon P, Siena F, Armstrong J. Tracheal intubation: improving first pass success with smart material solutions. J Healthc Des. 2017;2(3):15–18.

 Google Scholar

National Hospital Ambulatory Medical Care Survey. 2018 emergency department summary tables; 2018.

 Google Scholar

Goto T, Goto Y, Hagiwara Y, Okamoto H, Watase H, Hasegawa K. Advancing emergency airway management practice and research. Acute Med Surg. 2019;6(4):336–351. doi:10.1002/ams2.428

 PubMed Web of Science ®Google Scholar

Offenbacher J, Nikolla DA, Carlson JN, et al. Incidence of rescue surgical airways after attempted orotracheal intubation in the emergency department: a National Emergency Airway Registry (NEAR) study. Am J Emerg Med. 2023;68:22–27. doi:10.1016/j.ajem.2023.02.020

 PubMed Web of Science ®Google Scholar

Heymans F, Feigl G, Graber S, Courvoisier DS, Weber KM, Dulguerov P. Emergency cricothyrotomy performed by surgical airway–naive medical personnel: a randomized crossover study in cadavers comparing 3 commonly used techniques. Obstet Anesth Dig. 2017;37(2):79. doi:10.1097/01.aoa.0000515750.60577.e7

 Google Scholar

Pournajafian A, Alimian M, Rokhtabnak F, Ghodraty M, Mojri M. Success rate of airway devices insertion: laryngeal mask airway versus supraglottic gel device. Anesth Pain Med. 2015;5(2):e22068. doi:10.5812/aapm.22068

 PubMedGoogle Scholar

Huang TY, Lin JR, Chung YT. A preinstalled nasopharyngeal airway in the right nasal passageway to facilitate nasogastric intubation in anesthetized and intubated patients: a prospective randomized controlled trial. BMC Gastroenterol. 2020;20(1):365. doi:10.1186/s12876-020-01514-6

 PubMed Web of Science ®Google Scholar

Anesthesia Airway Management (AAM). Home. Available from: https://aam.ucsf.edu/. Accessed June 20, 2023.

 Google Scholar

UpToDate. Management of the difficult airway for general anesthesia in adults; 2023. https://www.uptodate.com/contents/management-of-The-difficult-airway-for-general-anesthesia-in-adults. Accessed June 20, 2023.

 Google Scholar

Wong E, Ng YY. The difficult airway in the emergency department. Int J Emerg Med. 2008;1(2):107–111. doi:10.1007/s12245-008-0030-6

 PubMedGoogle Scholar

Turner JS, Bucca AW, Propst SL, et al. Association of checklist use in endotracheal intubation with clinically important outcomes: a systematic review and meta-analysis. JAMA Netw Open. 2020;3(7):e209278. doi:10.1001/jamanetworkopen.2020.9278

 PubMed Web of Science ®Google Scholar

Zenios S, Makower J, Yock P. Biodesign: The Process of Innovating Medical Technologies. Cambridge University Press; 2010.

 Google Scholar

Amornyotin S, Prakanrattana U, Vichitvejpaisal P, Vallisut T, Kunanont N, Permpholprasert L. Comparison of the clinical use of Macintosh and Miller laryngoscopes for orotracheal intubation by second-month nurse students in anesthesiology. Anesthesiol Res Pract. 2010;2010. doi:10.1155/2010/432846

 PubMedGoogle Scholar

Mulcaster JT, Mills J, Hung OR, et al. Laryngoscopic intubation: learning and performance. Anesthesiology. 2003;98(1):23–27. doi:10.1097/00000542-200301000-00007

 PubMed Web of Science ®Google Scholar

Endotracheal tube market size, share & trends analysis report by product type (regular, reinforced), by route type (orotracheal, nasotracheal), by application, by end-user, by region, and segment forecasts, 2023–2030. Available from: https://www.grandviewresearch.com/industry-analysis/endotracheal-tubes-market. Accessed June 20, 2023.

 Google Scholar

Global Industry Analysts, Inc. Global airway management devices market to reach $1.8 billion by 2024. PR Newswire; 2021. Available from: https://www.prnewswire.com/news-releases/global-airway-management-devices-market-to-reach-1-8-billion-by-2024--301350115.html. Accessed June 20, 2023.

 Google Scholar