Improving Trans-oral Surgical Outcomes Through Intra-operative Image Guidance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy
研究概览
简要总结
The objective of this research is to perform a pilot study on patients undergoing laryngoscopy for diagnostic and tumor staging purposes (for pharyngeal or laryngeal cancer) in which intraoperative CT imaging will be performed both prior to (but after induction of general endotracheal anesthesia) and during placement of the laryngoscope in order to better understand anatomic changes that occur during instrumentation of the oral cavity and oropharynx. The goals of the study are:
- Develop a suite of de-identified images and surface renderings that qualitatively show how a tumor and the upper aerodigestive tract anatomy deform during a laryngoscopic evaluation.
- Create deformation models of the upper aerodigestive tract.
This data to be used for future retractor development as well as for virtual image guided surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years) seen in the Head and Neck Tumor Clinic who will require laryngoscopy in the operating room for diagnosis and staging of known or suspected tumors of the upper aerodigestive tract.
排除标准
- •Patients who are unable to tolerate general anesthesia.
- •Patients who are felt to be a "difficult airway" for induction of general endotracheal anesthesia.
- •Patients with excessive dental restorations and amalgam.
结局指标
主要结局
Radiographic evidence of upper aerodigestive tract deformation during laryngoscopy
时间窗: Collected at the time of surgery
次要结局
未报告次要终点
研究者
Joseph A. Paydarfar
Staff Physician
Dartmouth-Hitchcock Medical Center