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We recognize that change can be unsettling ― especially when it comes to life-sustaining products like tracheostomy tubes.

We’re here to help with resources that share key insights into our product enhancements and provide support for your transition to Shiley™ flexible tracheostomy tubes.

Innovation to advance patient outcomes

Shiley™ tracheostomy tubes have been on the market for over 50 years. We are dedicated to evolving our products to meet the needs of clinicians and patients while aligning with global regulations, medical device standards, and regulatory organizations such as the FDA and EU MDR.

Our legacy Shiley™ tracheostomy tubes are outdated for the needs of today’s patients, industry guidelines, and regulatory specifications.

We designed our Shiley™ flexible (flex) tracheostomy portfolio to meet the latest regulations and standards, support the needs of doctors and caregivers, and ― most critically ― advance patient outcomes.

Learn about the differences between the legacy and updated products.

Tracheostomy Sizing Guide

Discover the importance that tracheostomy sizing plays in obtaining a proper cuff seal and minimizing tracheal damage and other negative outcomes.

Expanded sizes and insertion options

Each patient’s needs are unique. The Shiley™ flex tracheostomy portfolio expands our offering, providing more choices to effectively address clinical decision-making, insertion options, and patient sizing needs.

We now offer seven sizes, including half sizes, compared to the four legacy sizes. Our expanded size offering supports more effective cuff sealing ― without overinflating the cuff or causing tracheal damage. It also helps support longer-term trach wearers who may need to size up over time.

Understanding the product sizing

Our updated product labeling has created some challenges in understanding product sizing. Here’s what you need to know.

The product reference code (REF) on Shiley™ flex tracheostomy tubes indicates:

  • The Jackson size
  • Whether the tube is cuffed or uncuffed
  • The ISO size and the inner diameter of the outer cannula
  • If the inner canula is disposable or reusable

For a comparable size to the legacy Shiley™ tracheostomy tubes, reference the first number ― the Jackson size ― in the product code of Shiley™ flex tracheostomy tubes.

A flange for patient comfort and clinician workflow

Legacy Shiley™ tracheostomy tubes had a rigid flange made of firm, opaque PVC material, which made visualization of the underlying skin difficult.

Our enhanced Shiley™ flex tracheostomy tubes feature a smaller, softer flange that conforms to the patient’s anatomy and has less contact with the sensitive skin around the stoma.

The flange is recessed to reduce contact with the stoma site and facilitate airflow to the skin, which can be difficult to keep dry. The clear, transparent material offers enhanced visualization of the underlying skin.

One hospital system reported an 80% decrease in tracheostomy-related pressure ulcers after incorporating Shiley™ flex tracheostomy tubes into their skin care bundle.1

An integrated 15 mm connector for when you need it most

Shiley™ flexible tracheostomy tubes include an integrated 15 mm connector. Compared to legacy Shiley™ tracheostomy tubes, on which the inner cannula had to be in place to attach ventilation equipment, the 15 mm connector on Shiley™ flex tracheostomy tubes is in place with or without the inner cannula. So, in the event of an emergency, necessary equipment can be attached regardless of inner cannula use.

Inner cannula options to support varying needs and accessories

The Shiley™ flex tracheostomy portfolio includes both disposable and reusable options. The inner cannulas are now easier to move and replace.

The newer inner cannulas securely snap in with light pressure, an advancement over the heavier pressure, pinching, and twisting motion required by legacy Shiley™ tracheostomy tube cannulas ― which could be difficult for some patients with strength or dexterity challenges.

The flush inner cannula design on Shiley™ flex tracheostomy tubes facilitates the 15 mm connector’s compatibility with general ventilator and tracheostomy accessories.

Speaking with Shiley™ flex tracheostomy tubes

Shiley™ flex tracheostomy tubes require a different approach to speaking compared to legacy Shiley™ tubes.

Our Shiley™ speaking valve is designed to be used in conjunction with our tracheostomy tubes to optimize oral communications.

When attached to the 15 mm connector on the Shiley™ flex tracheostomy tube, the speaking valve enables phonation by redirecting airflow through the vocal cords, nose, and mouth.

Alternative options for speaking with Shiley™ flex tracheostomy tubes include removing the inner cannula or finger occlusion using a gauze pad.

Comprehensive airway care from the TaperGuard™ cuff

Shiley™ flex tracheostomy tubes feature the taper-shaped TaperGuard™ cuff. The legacy product featured the barrel-shaped cuff design.

TaperGuard™ technology has been shown to:

  • Improve airway sealing by 91%2,†
  • Improve ventilatory pressure maintenance and titrate ventilator air leaks with 65% greater ability3,†
  • Decrease leaking of fluid past the cuff by 99%3,†
  • Decrease lateral wall pressure on the trachea by 18.6%3,†
  • Decrease mucosal injury and inflammation of the mucosal wall4,†
  • Retract closer to the shaft of the tube due to the less bulky cuff material, which may help ease insertion and weaning4,†
  • Allow 242% more airflow to pass around the cuff when deflated, which may reduce the work of breathing required to speak and wean5,†

Clinician-inspired solutions for patient care, patient comfort, and clinical convenience

We are dedicated to Engineering the extraordinary. We infuse our passion for innovation with feedback from clinicians, patients, and data-driven research to continually evolve our products to advance patient outcomes.

Discover how we designed our Shiley™ flexible tracheostomy tubes to support easier initial placement, improved trachea and lung protection, and enhanced comfort and skin care.

For use by trained personnel only. The tracheostomy tube and obturator are sterile, single-use patient medical devices not intended to be reprocessed (cleaned, disinfected/sterilized) and used on another patient. Duration of use should not exceed twenty-nine (29) days. Please refer to the product instructions for use (IFU) for detailed usage and troubleshooting instructions.

†Compared to legacy Shiley™ tracheostomy tubes.

References

  1. Dixon LM, Mascioli S, Mixell JH, Gillin T, Upchurch CN, Bradley KM. Reducing tracheostomy-related pressure injuries. AACN Adv Crit Care. 2018;29(4):426–431. doi:10.4037/aacnacc2018426.
  2. Maguire S, Haury F, Jew K. An in vitro comparison of tracheostomy tube cuffs. Med Devices (Auckl). 2015;8:185–192. doi: 10.2147/MDER.S76960.
  3. Internal benchtop testing results. Results reflect the Shiley™ flexible adult tracheostomy tube with TaperGuard™ cuff, disposable inner cannula tubes ability to titrate/control ventilator air leak in comparison to the Shiley™ tracheostomy tube cuffed with disposable inner cannula (DCT). Benchtop test #10122514.
  4. Berges AJ, Lina IA, Ospino R, et al. Impact of low-volume, low-pressure tracheostomy cuffs on acute mucosal injury in swine. Otolaryngol Head Neck Surg. 2022;167(4):716–724. doi: 10.1177/01945998221119160.
  5. Internal bench-top testing results. Results reflect testing the Shiley™ flexible adult tracheostomy tube with TaperGuard™ cuff, disposable inner cannula versus the Shiley™ DCT tracheostomy tube with disposable inner cannula at the same cuff pressure of 25 cm H2O. Benchtop test #10122514.