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
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).
研究概览
详细说明
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.
研究类型
阶段
- 不适用
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Sage Guard Intervention
Participants will wear the Sage Guard device during the study procedure to evaluate its feasibility, safety, usability, and effectiveness in protecting vital structures of the oral cavity. |
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. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Incidence of oral trauma in intubated patients
大体时间：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. |
Daily assessment up to Day 21
|
|
Incidence of endotracheal tube displacement in intubated patients
大体时间：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. |
Daily assessment up to Day 21
|
|
Incidence of endotracheal tube damage in intubated patients
大体时间：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. |
Daily assessment up to Day 21
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Frequency of movement of study device position during endotracheal intubation
大体时间：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. |
Daily assessment up to Day 21
|
|
Likert Scale Scores of study device use by bedside nursing staff
大体时间：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. |
Daily assessment up to Day 21
|
合作者和调查者
调查人员
- 学习椅：Amir Taha, DDS、Obsolete Engineering Co.
- 首席研究员：Jesus A. Valdez, DDS、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- IRB00149615
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data (IPD) will not be shared. Due to the small sample size in this pilot feasibility study, sharing de-identified participant-level data could increase the risk of participant re-identification and compromise confidentiality.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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