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临床试验/NCT05307900
NCT05307900已完成不适用

Ultrasonography Confirmation of Feeding Tube Placement in Critically Ill Patients

Universiti Kebangsaan Malaysia Medical Centre2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年12月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
65
试验地点
2
主要终点
To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography

研究概览

简要总结

To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography

详细描述

Patients who are indicated for feeding tube (FT) placement in ICU will be recruited in this study. Written informed consent will be obtained from next of kin.

Feeding tubes will be inserted by ICU oncall anaesthesiologist as per protocol. The FTof polyvinyl chloride with calibre of 12-16 French will be used. The Nose-Ear-Xiphoid method will be used to measure the tube insertion distance, adding the distance from tip of the patient's nose to the earlobe and from the earlobe to the xiphoid. The tip of tube lubricated prior to insertion in all cases. Orogastric tube placement will be done if nasal route placement is unsuccessful or contraindicated.

Once the correct placement is confirmed by auscultation and aspirate method, the tube will be secured to patient's nose with adhesive tape. For the purpose of this study, verification of tube placement will be done with bedside ultrasound prior to X-ray.

Ultrasound verification of tube placement will be done by a single investigator who received training on oesophageal and gastric ultrasound from radiologist. 'Sonosite SII' (by Fujifilm Sonosite, Inc) ultrasound machine will be used to conduct this study. A linear probe (L38xi, 10-5MHz) will be placed transversely at the anterior neck and focused on visible part of oesophagus which will be just below the left thyroid lobe. A curved probe (C35x, 8-3MHz) will be placed at subxiphoid area orientated towards left upper abdominal quadrant to visualize the stomach and by angulating the probe towards the left subcostal area, the gastric body can be identified in transversal plane just beside the left lobe of liver as internal landmark.

The ultrasound examination will be considered positive if the FT visualized as a hyperechogenic circle posterior to left thyroid lobe adjacent to trachea, and as a hyperechogenic point in the stomach. If the FT seen in the oesophagus and not in stomach, a 20mls of air will be injected through the FT using pine tip syringe while observing dynamic fogging in the stomach. FT is considered in the gastric body in the presence of fogging. Total duration of ultrasound confirmation of FT will be recorded. Following completion of ultrasound confirmation of FT, a chest x-ray will be done for all the patients as per usual. The chest x-ray will be reviewed by ICU team who are blinded from this study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All the patients, aged > 18 years old that admitting to ICU who require feeding tube insertion

排除标准

  • Any contraindications for FT insertion. e.g. coagulopathy, oesophageal varices
  • History or post gastric by-pass surgeries
  • Known history of nasopharyngeal, oesophagus or stomach carcinoma
  • Neck trauma/swelling including goitre
  • Open wounds at neck or epigastric regions
  • Pregnant patients

结局指标

主要结局

To compare the correct placement of feeding tube in critically ill patients in ICU using ultrasonography versus chest radiography

时间窗: 1 year

Numbers of positive ultrasound verifications of correct placement of feeding tube

次要结局

  • To study time taken to perform USG examination to confirm feeding tube placement in critically ill patients(1 year)

研究者

发起方
Universiti Kebangsaan Malaysia Medical Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rufinah Teo

Lecturer and Consultant Anesthesiologist , Department of Anesthesia and Intensive Care

Universiti Kebangsaan Malaysia Medical Centre

研究点 (2)

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