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临床试验/NCT04066686
NCT04066686已完成不适用

Evaluation on the Level of Discomfort and Restriction on Activities of Daily Living (ADLs) Whilst C-spine Immobilised in a Spinal Collar After C-spine Injury.

Imperial College Healthcare NHS Trust1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2018年10月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
1
主要终点
Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury.

研究概览

简要总结

This is an observational study which aims to assess the comfort of a spinal collar in patients who have them fitted as part of their clinical care due to neck injury.

详细描述

The study follows the patient journey including long term follow up (up to 120 days following admission). The information gathered will be from the standard clinical care delivered and include demographics, baseline function, the injuries sustained following trauma and prescribed analgesia with records of the most recent time and dose administered. Any scans done of the neck for clinical purposes will be anonymised and analysed for measurements of angulation. In addition to this there will be a survey on the comfort of the collar and of their functional ability at the current time at various points during their inpatient admission.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

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

入选标准

  • All patients aged 18yrs and over with a C-spine injury immobilised in a spinal collar
  • Patients must be nursed on Major Trauma Ward
  • Ability to give informed consent to participate in the study.

排除标准

  • Patients under 18yrs age
  • Patients who lack capacity to consent for entry into the study
  • Patients who are receiving level 2( High dependency unit) or level 3 (Intensive care unit) clinical care
  • Patients who are unable to complete the visual analogue score or questionnaire due to having co-existent severe hearing and visual impairment. Severe hearing impairment will be defined as unable to hear the researcher with hearing aids if required. Severe visual impairment will be defined as being unable to read the patient information sheet even with visual aids.
  • Patients unable to understand the patient leaflet in English.

结局指标

主要结局

Measurement of the Level of Discomfort Produced by the Spinal Collar in Adult Patients With a C-spine (Neck) Injury.

时间窗: During inpatient admission (an average of two weeks)

'Visual Analogue Scale' for pain (self reported: minimum 0=no pain at all, maximum 10= worst pain imaginable)

次要结局

  • Measurement of Change of Impedance on Activities of Daily Living Produced by the Spinal Collar in Adult Patient With a C-spine (Neck) Injury.(At baseline (retrospectively) and at time of wearing the spinal collar after injury)
  • Measurement of Spinal Angulation(Through study completion, up to one year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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