Pilot Feasibility Study to Evaluate the Efficacy, Safety, and Usability of the Sage Guard for Protecting the Vital Structures of the Oral Cavity
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Incidence of oral trauma in intubated patients
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 不适用
- 干预模型
- 单组
- 主要目的
- 预防
- 盲法
- 开放（无盲法）
入排标准
- 年龄范围
- 13 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 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
排除标准
- 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
研究组 & 干预措施
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.
干预措施: Sage Guard oral protection device (Device)
结局指标
主要结局
Incidence of oral trauma in intubated patients
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Frequency of movement of study device position during endotracheal intubation(Daily assessment up to Day 21)
- Likert Scale Scores of study device use by bedside nursing staff(Daily assessment up to Day 21)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT07806812
- 其他研究编号
- IRB00149615
日期
- 首次提交
- (上个月)
- 首次发布
- (22天前)
- 主要完成日期
- (2年后)
- 研究完成日期
- (2年后)
- 最近核实
- (2个月前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 是
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
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.