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临床试验/NCT06821737
NCT06821737已完成不适用

Diagnostic Accuracy of Using Point-of-care Ultrasonography for Confirming Nasogastric Tube Placement: a Multicentre Prospective Study

Pamela Youde Nethersole Eastern Hospital1 个研究点 分布在 1 个国家目标入组 675 人开始时间: 2025年4月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
675
试验地点
1
主要终点
Diagnostic Accuracy of Ultrasound in correct Nasogastric Tube placement confirmation

研究概览

简要总结

A prospective observational diagnostic study will be conducted to assess the sensitivity and specificity of ultrasound in verifying the correct nasogastric tube placement, using X-ray as the reference standard.

详细描述

This study is a prospective observational diagnostic investigation aimed at evaluating the accuracy of ultrasound in confirming nasogastric tube (NGT) placement. Participants aged 18 years or older requiring NGT insertion will be recruited via convenience sampling from community nursing centres across five clusters and medical and geriatric wards in four acute or convalescent hospitals. Nurses performing index tests will complete standardized POCUS training (8-hour theory and practical sessions, written exams, 3-month bedside practicum with ≥20 positive scans) prior to competency assessment. Direct visualisation of an NGT in both the oesophagus and stomach will be interpreted as correct stomach placement. When the acoustic shadow of an NGT was not seen in the stomach, 50cc of air was injected through the NGT, and it was considered well-placed if the ultrasonography showed dynamic fogging. Correct gastric placement is assumed if the acoustic shadow of an NGT is visible in the oesophagus and stomach, even if fogging is not detectable. The reference standard will be post-index test X-ray confirmation. Diagnostic performance metrics, including sensitivity, specificity, positive and negative predictive values, and likelihood ratios, will be calculated to assess the efficacy of ultrasound. Variability in diagnostic accuracy across participant characteristics will be analyzed. Additionally, the study will compare the time intervals between ultrasound and X-ray, delays in feeding initiation post-placement, and associated costs, including emergency department admissions, unplanned hospitalizations, and ambulance transportation.

The findings will provide critical evidence on the diagnostic utility of ultrasound for NGT placement verification, informing potential revisions to clinical practice guidelines and supporting stakeholder decisions on integrating ultrasound as a reference test.

研究设计

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

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

  • Aged 18 or older;
  • Living in the community or admitted to a medical and geriatric ward;
  • Requiring the use of an NGT during the recruitment period for assessment, monitoring, nutritional assistance, drainage, and/or medication administration;
  • Aspirated fluids with a pH value of more than 5.5 after insertion or with insufficient fluids for pH testing after insertion;

排除标准

  • Uncooperative patients;
  • Had head and neck injury
  • Have had a gastrectomy or by-pass surgery;
  • History of abdominal trauma or receiving emergency life support intervention at time of recruitment.

研究组 & 干预措施

Observational Group

All participants included will be in one observational cohort.

干预措施: Diagnostic ultrasound (Device)

Observational Group

All participants included will be in one observational cohort.

干预措施: Diagnostic X-ray (Device)

结局指标

主要结局

Diagnostic Accuracy of Ultrasound in correct Nasogastric Tube placement confirmation

时间窗: An average of 18 months

Sensitivity: True Positive / (True Positive + False Negative) x 100% Specificity: True Negative / (True Negative + False Positive) x 100% Positive Predictive Value: True Positive / (True Positive + False Positive) x 100% Negative Predictive Value: True Negative / (True Negative + False Negative) x 100% Positive Likelihood Ratio: sensitivity / 1 - specificity Negative Likelihood Ratio: 1 - sensitivity / specificity

次要结局

  • Time lag between USG & x-ray(An average of 18 months)
  • Delay between tube placement and feeding by x-ray(An average of 18 months)
  • Cost of ED admission, unplanned admission, ambulance transportation(An average of 18 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mak Mei Yi

Nurse Consultant

Pamela Youde Nethersole Eastern Hospital

研究点 (1)

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