Biomechanical Analysis of Force Loadings During Suspension Microlaryngoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Short Form McGill Pain Questionnaire (SF-MPQ)
研究概览
简要总结
This research is to understand more about the forces that are involved on the tongue and other oropharyngeal structures during laryngeal surgery. This information will be used to determine if these forces can affect outcomes (pain, numbness, taste, etc) and whether factors such as procedure type, surgeon experience (i.e. resident, fellow, attending), and choice of surgical equipment affect these forces. This information may be used to reduce these forces and prevent these issues from happening during certain laryngeal surgeries.
For the first 50 patients, force measurements will be taken and correlated to outcome measures . Surgeons will be blinded to the force measurements intra-operatively.
For the next 50 patients, surgeons will be given force measurements in real-time intra-operatively allowing adjustments to be made. The impact of this adjustment on outcomes will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 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
- •>18 years old with
- •undergoing laryngeal surgery with direct laryngoscopy
排除标准
- •Prior history of tongue dysfunction such as glossectomy (hemi or total) or hypoglossal nerve injury
- •Patient inability to follow up after initial procedure
研究组 & 干预措施
Surgeon blinded
Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. Post-operative outcome measures will be collected.
干预措施: Direct laryngoscopy without force modulation (Procedure)
Surgeon unblinded
Patients will undergo direct laryngoscopy with force measurements taken intra-operatively. The surgeon will be aware of force measurements in real-time, allowing for adjustments to reduce applied force during direct laryngoscopy. Post-operative outcome measures will be collected.
干预措施: Direct laryngoscopy force modulation (Procedure)
结局指标
主要结局
Short Form McGill Pain Questionnaire (SF-MPQ)
时间窗: 1 day, 14 days, and 1 month post-operatively
The SF-MPQ includes the following components: 15 descriptors: * 11 sensory, each rated 0=none, 1=mild, 2=moderate, 3=severe * 4 affective , each rated 0=none, 1=mild, 2=moderate, 3=severe. A Present Pain Intensity (PPI) scale (0=No Pain, 1=Mild, 2=Discomforting, 3=Distressing, 4=Horrible, 5=Excruciating) Visual Analogue Scale of average pain (VAS, 0-10 cm) - higher score is worse pain
次要结局
- Tongue mobility(1 month post-operatively)
- Tongue sensation(1 day, 14 days, and 1 month post-operatively)
- Change in taste(1 day, 14 days, 1 month post-operatively)