Transoesophageal echocardiography (TOE) in the early assessment of shocked trauma: A pilot study of a novel disposable miniaturised TOE device in the first hour of resuscitation.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- This is a feasibility study, assessing the clinicians ability to assess shock using the device. The primary outcome is the collapsibility index of the superior vena cava (two measurements of the maximum and minimum width of the SVC) as a validated marker of hypovolaemia. This will be reported as the proportion of patients where clinicians are able to achieve views of the heart sufficient to calculate this index within 10 minutes of insertion of the probe.[ After completing the examination the clinician will report their findings into an App based survey. The primary timepoints will be whether the clinician could obtain the necessary views of the heart within 10 minutes of insertion. This data entry will be completed as soon after the procedure as patient stability allows (likely within 60 minutes).]
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 No limit（—）
- 性别
- All
入选标准
- •Intubated major trauma patients presenting during the study periodAge 18 years and overPresenting directly from scene of injuryMeeting ‘shocked trauma’ callout criteria:- Systolic blood pressure (SBP) less than 90mmHg at any time- Shock index > 1 (Heart Rate/SBP)- Prehospital blood transfusion
排除标准
- •Not requiring intubation either prehospital or within 1 hour of arrival to the ED- Deceased on arrival- An Advanced Care Directive that precludes resuscitation
结局指标
主要结局
This is a feasibility study, assessing the clinicians ability to assess shock using the device. The primary outcome is the collapsibility index of the superior vena cava (two measurements of the maximum and minimum width of the SVC) as a validated marker of hypovolaemia. This will be reported as the proportion of patients where clinicians are able to achieve views of the heart sufficient to calculate this index within 10 minutes of insertion of the probe.[ After completing the examination the clinician will report their findings into an App based survey. The primary timepoints will be whether the clinician could obtain the necessary views of the heart within 10 minutes of insertion. This data entry will be completed as soon after the procedure as patient stability allows (likely within 60 minutes).]
次要结局
未报告次要终点