Search > Intubation
My employer runs this trial

Sage Guard for Intubation

JA
AT
Overseen ByAmir Taha, DDS
Age: Any Age
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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).

Who Is on the Research Team?

AT

Amir Taha, DDS

Principal Investigator

Obsolete Engineering Co.

JA

Jesus A. Valdez, DDS

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for ICU patients who need a breathing tube (intubation). People with conditions that would make using an oral device unsafe or impossible are not eligible.

Inclusion Criteria

I am in the ICU and currently on a breathing machine.
I have upper and lower teeth that meet on both sides of my mouth.
Attending physician requested a dental evaluation as part of the patient's care

Exclusion Criteria

I do not have severe facial or jaw injuries that prevent device placement.
Known allergy to thermoplastic polyurethane (TPU)
I have baby teeth, a mix of baby and adult teeth, or no teeth at all.
See 1 more

What Are the Treatments Tested in This Trial?

Interventions

  • Sage Guard oral protection device

Trial Overview

The study is testing the Sage Guard, a soft mouth device used during intubation to protect the mouth and throat from injury, keep teeth apart, hold the tongue aside, and help secure the breathing tube. The focus is on safety and ease of use.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Sage Guard InterventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

Obsolete Engineering Co.

Collaborator

Unbiased Results

We believe in providing patients with all the options.

Your Data Stays Your Data

We only share your information with the clinical trials you're trying to access.

Verified Trials Only

All of our trials are run by licensed doctors, researchers, and healthcare companies.