Pilot Study of the Sage Guard for Oral Cavity Protection

Pilot Feasibility Study to Evaluate the Efficacy, Safety, and Usability of the Sage Guard for Protecting the Vital Structures of the Oral Cavity

During placement of a breathing tube, a soft device will be placed in the mouth to help keep the teeth apart and hold the tongue out of the way. This device is designed to help protect the mouth and throat from injury caused by biting, which can lead to swelling or infection. It may also help keep the breathing tube in place and prevent damage to the tube from being bitten. The study will evaluate how safe the device is and how easy it is for healthcare providers to use in patients receiving care in the Intensive Care Unit (ICU).

A device will be placed in participants that are intubated in the ICU. The device will remain in place for up to 21 days, removal of the device will coincide with extubation. Surveys will be completed by experienced healthcare providers in the ICU to answer work related questions and provide a baseline for oral trauma in the ICU while intubated. Bedside nurses will be asked to answer questions about their experience with the device during participant use to understand ease of usability and integration into the workflow.

Inclusion Criteria:

• Intubated ICU patients on mechanical ventilation
• 2 sets of opposing teeth that occlude on both left and right sides
• Attending physician requested a dental evaluation as part of the patient's care

Exclusion Criteria:

• Active oral infection or trauma preventing safe device placement
• Known allergy to thermoplastic polyurethane (TPU)
• Severe facial or jaw trauma incompatible with device placement
• Mixed dentition, primary dentition, and edentulous patients