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Pilot Study of the Sage Guard for Oral Cavity Protection
Sponsor: Wake Forest University Health Sciences
Summary
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).
Official title: Pilot Feasibility Study to Evaluate the Efficacy, Safety, and Usability of the Sage Guard for Protecting the Vital Structures of the Oral Cavity
Key Details
Gender
All
Age Range
13 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
0
Start Date
2027-08
Completion Date
2028-11
Last Updated
2026-09-28
Healthy Volunteers
No
Conditions
Interventions
Sage Guard oral protection device
The study device is a single-use mouth device made of a soft plastic material (thermoplastic polyurethane). It has side bite blocks that help keep the teeth apart, a center support that helps hold the breathing tube in place, and tongue guards that help protect the tongue from injury. The device is designed for use in patients with an endotracheal (breathing) tube to help prevent injury to the mouth and tongue caused by biting and to help keep the breathing tube stable.