跳至主要内容
临床试验/NCT02092493
NCT02092493撤回不适用

The Effect of Magnetic Endoscopic Imaging (ScopeGuide) on the Mental Workload of Endoscopists During Colonoscopy

University Hospital Southampton NHS Foundation Trust2 个研究点 分布在 1 个国家开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
mental workload scores for endoscopist performing colonoscopy (represented by the NASA-task load index scores on a visual analogue scale (VAS) ranging from 0-600)

研究概览

简要总结

ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which provides real-time 3D image of the shape and configuration of the colonoscope as it travels through the colon. Whilst it is being used in clinical practice in most units in the UK, it is not a device which is routinely used on all lists, and most departments do not own enough ScopeGuides to have on all lists. Studies have shown it can potentially aid colonoscopy by improving completion rates and times as well as patient comfort in selected endoscopists (persons who perform the colonoscopy). However data on its benefit have been conflicting.

Subjective mental workload (the individuals mental resources required as a result of the multiple demands placed on him/her from a task)in healthcare employees is known to be important for the performance and safety of healthcare delivery. Increased workload during task performance may increase fatigue, facilitate errors and lead to overall inferior performance.

In colonoscopy high mental workload could potentially be responsible for longer procedural time, lack of trainee learning, inadvertent missing of lesions in the bowel as well as poor technique leading to patient discomfort. The effect of the endoscopist mental workload on their performance and potential facilitators to reduce mental workload is an area that has been neglected in this field.

This study aims to look at the mental workload of endoscopist during colonoscopy and the effect ScopeGuide may have on this workload.

Hypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the endoscopist performing the procedure

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All endoscopist performing colonoscopy at University hospital Southampton endoscopy unit
  • All adult patients attending diagnostic colonoscopy

排除标准

  • Endoscopist preference
  • Patients unable to give informed consent
  • Patient preference
  • Patients with new diagnosis of colonic cancer

结局指标

主要结局

mental workload scores for endoscopist performing colonoscopy (represented by the NASA-task load index scores on a visual analogue scale (VAS) ranging from 0-600)

时间窗: within 1 hour of beginning procedure

This will be a brief VAS scale questionnaire carried out when the endoscopist reaches the caecum

Caecal intubation times, recorded in minutes and seconds

时间窗: within 1 hour of beginning procedure

this would be the time it takes from the beginning of the procedure to reaching the caecum

次要结局

  • Withdrawal time measured in minutes and second(within 1 hour of beginning procedure)
  • Overall procedure times in minutes and seconds(within 1 hour of beginning procedure)
  • -'Timing' of procedures (day & am/pm & order on list)(upto 1 hour before beginning procedure)
  • Polyp detection(within 1 hour of beginning procedure)
  • Patient comfort scores on a visual analogue scale(within 1 hour of completing procedure)
  • Sedation dose measured in milligrams and micrograms(within 1 hour of completing procedure)
  • Patient pre-endoscopy anxiety levels measured on visual analogue scale(upto 1 hour before beginning procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验