Intubated Patients
Conditions
Keywords
endotracheal tube damage and clearance, Intensive care unit intubated patients, Intensive care unit oral trauma
Brief summary
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).
Detailed description
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.
Interventions
DEVICESage 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.
Sponsors
Wake Forest University Health Sciences
Obsolete Engineering Co.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of oral trauma in intubated patients | Daily assessment up to Day 21 | The occurrence of oral injuries, including injury to the tongue, lips, cheeks, gums, or other oral tissues, during the period of endotracheal intubation. The incidence of oral trauma will be compared between patients managed with the study device and those receiving standard care. |
| Incidence of endotracheal tube displacement in intubated patients | Daily assessment up to Day 21 | The occurrence of endotracheal tube movement from its intended position during the period of intubation. The incidence of tube displacement will be compared between patients managed with the study device and those receiving standard care. |
| Incidence of endotracheal tube damage in intubated patients | Daily assessment up to Day 21 | The occurrence of endotracheal tube damage during the period of intubation. The incidence of tube damage will be compared between patients managed with the study device and those receiving standard care. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of movement of study device position during endotracheal intubation | Daily assessment up to Day 21 | The occurrence of movement of the study device from its intended position during the period of endotracheal intubation. The frequency of device displacement events will be recorded. |
| Likert Scale Scores of study device use by bedside nursing staff | Daily assessment up to Day 21 | Feasibility will be assessed by nursing staff using a standardized questionnaire evaluating ease of device placement, maintenance, removal, and integration into routine patient care workflow. A Likert scale is scored by assigning numbers to each answer choice. You then add up or average these numbers to turn soft feelings into hard data. A standard five-point scale gives a score of 1 to 5 for each question - Higher totals mean more of that trait or feeling. |
Countries
United States
Contacts
CONTACTJesus A. Valdez, DDS
CONTACTAmir Taha, DDS
STUDY_CHAIRAmir Taha, DDS
Obsolete Engineering Co.
PRINCIPAL_INVESTIGATORJesus A. Valdez, DDS
Wake Forest University Health Sciences
Outcome results
None listed