Placement of Novel Endoscopic Enteral Feeding Tube (LEGEND)
Placement of Novel Endoscopic Enteral Feeding Tube - A Feasibility Study
研究概览
详细说明
Enteral feeding is the preferred route of nutrient delivery in hospitalized patients who cannot eat sufficiently. Placement of enteral feeding tubes carries a risk of misplacement especially in patients who are unable to fully collaborate during the tube placement due to neurological impairment and/or the presence of an artificial airway. The misplacement of a feeding tube in the airways has a high risk of severe complications, including pneumonia, mechanical damage of airways and the lung, and death. The verification of correct tube placement can be done using radiography, or interventions aimed at confirming the location of the tube tip by aspiration of gastric contents, and by auscultation during injection of air.
Approximately 20-25 % of patients treated in intensive care units are likely to need placement of a feeding tube, while undergoing mechanical ventilation and having an artificial airway. This high risk patient group would benefit from technologies allowing direct visualization of tube placement. It is also expected that direct visualization of tube placement will allow confirmation of tube placement and therefore eliminate the need of radiography (radiation).
研究类型
注册 (实际的)
联系人和位置
学习地点
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Bern、瑞士、3010
- Universitätsklinik für Intensivmedizin
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
Healthy volunteers
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Age >18 years
Patients
- Age >18 years
- mechanically ventilated and requiring a placement of a postpyloric feeding tube on clinical indications
- Informed Consent as documented by signature of relatives
Exclusion Criteria:
Healthy volunteers and patients
- Unrepaired tracheoesophageal fistula
- history of prior esophageal or gastric surgery
- esophageal obstruction, stricture, varices or diverticulum
- esophageal or gastric perforation, gastric or esophageal bleeding
- recent oropharyngeal surgery
- cervical spine injury or anomaly
Additional exclusion criterion for patients only
• know severe coagulopathy (defined as thrombocyte count less than 30x10e9/l or International Normalized Ratio (INR) > 3)
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：其他
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Volunteers
Cohort of 10 healthy subjects.
The tube will be placed and removed by a gastroenterologist experienced in performing endoscopic postpyloric tube placement.
Secondly, a second tube will be placed and removed.
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Placement of enteral feeding tubes
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Mechanically ventilated ICU
Cohort of 20 mechanically ventilated intensive care patients requiring a placement of a postpyloric feeding tube on clinical indications.
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Placement of enteral feeding tubes
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Success rate of postpyloric placement, time to reach intragastric and postpyloric position, ease of insertion, handling and image quality.
大体时间：During Intervention Visit, an average of 24 hours
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using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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In healthy volunteers, time required to reach gastric and postpyloric placement
大体时间：During Intervention Visit, an average of 24 hours
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Questionnaire with various positions and the time to reach the position
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During Intervention Visit, an average of 24 hours
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In healthy volunteers, ease of insertion, handling, and image quality assessed
大体时间：During Intervention Visit, an average of 24 hours
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Using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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In healthy volunteers, Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction
大体时间：During Intervention Visit, an average of 24 hours
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Using a visual analog scale of 1-10, with 1 indicating the best value.
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During Intervention Visit, an average of 24 hours
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In patients: Necessity of use of additional sedation/analgesia for the procedure in addition to already established sedation in the context of mechanical ventilation.
大体时间：During Intervention Visit, an average of 24 hours
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Questionnaire Yes/No and a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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In patients: Ease of insertion, handling, and image quality assessed using a visual analog scale of 1-10, with 1 indicating the best value.
大体时间：During Intervention Visit, an average of 24 hours
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using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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In patients: Usability of specific features - tip steerability, lens rinsing and flushing, air insufflation and fluid extraction.
大体时间：During Intervention Visit, an average of 24 hours
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using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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In patients: Subjective global assessment of the intensivist on whether or not the technique is suitable for clinical use in patients.
大体时间：During Intervention Visit, an average of 24 hours
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using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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In patients: Time required to reach gastric and postpyloric placement
大体时间：During Intervention Visit, an average of 24 hours
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Questionnaire
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During Intervention Visit, an average of 24 hours
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In patients: Feasibility of the feeding through Veritract tube.
大体时间：During Intervention Visit, an average of 24 hours
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using a visual analog scale of 1-10, with 1 indicating the best value
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During Intervention Visit, an average of 24 hours
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Bleeding and infection related to tube placement
大体时间：During Intervention Visit, an average of 24 hours
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AE/SAE Questionnaire Yes/No
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During Intervention Visit, an average of 24 hours
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Erroneous placement in larynx and trachea and associated complications (pneumothorax).
大体时间：During Intervention Visit, an average of 24 hours
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Outcome mesured with a questionnaire Yes/No
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During Intervention Visit, an average of 24 hours
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Injuries of the oesophagus, stomach or small intestine related to tube placement.
大体时间：During Intervention Visit, an average of 24 hours
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Outcome mesured with a questionnaire Yes/No
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During Intervention Visit, an average of 24 hours
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Reflux of stomach contents during tube placement
大体时间：During Intervention Visit, an average of 24 hours
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AE/SAE Questionnaire Yes/No
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During Intervention Visit, an average of 24 hours
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合作者和调查者
赞助
调查人员
- 首席研究员：Tobias Merz, Dr. med.、Inselspital Bern, Universitätsklinik für Intensivmedizin
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- 16.22.CLI
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