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临床试验/NCT06316986
NCT06316986已完成不适用

Performance of the NGPOD® Device in Verifying the Correct Position in the Stomach of the Naso- or Oro- Gastric Tube in Intensive Care : Prospective Monocentric Clinical Investigation

Fondation Hôpital Saint-Joseph2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Ability of the NGPOD device to detect correct positioning of the gastric tube.

研究概览

简要总结

In the Intensive Care Unit (ICU), scientific societies recommend starting enteral nutrition within 48 hours of admission, if oral nutrition is not available, in order to limit undernutrition. In patients who are sedated, have swallowing problems or cannot ensure adequate caloric intake, it is essential to insert a feeding tube, usually a nasogastric or orogastric tube for the first few weeks.

Placement of a naso- or oro-gastric tube in the intensive care unit is a frequent procedure, and considered to be straightforward. It is usually performed blindly, at the patient's bedside, by a nurse or doctor, according to a departmental protocol or the recommendations of learned societies.

Nevertheless, a number of complications have been reported with naso- or oro-gastric tubes, linked in particular to a route outside the digestive tract : malpositioning/coiling of the tube, epistaxis, sinusitis. The most frequent and potentially severe complications are malpositions in the tracheobronchial tree.

Radiographic control is currently considered in France and by certain learned societies to be the reference method for verifying correct positioning of the probe in the stomach (at the prepyloric antral level). However, thoracic radiography has a number of drawbacks : In intensive care risk of accidental displacement of other medical devices,irradiation, difficulty of interpretation, delay in obtaining the image, time-consuming work for qualified personnel.

An alternative technique using the NGPOD device is proposed as a method of checking the correct positioning of the probe in the stomach. This system enables immediate, rapid (15 seconds), simple and automatic testing at the patient's bedside. The device provides a visual indication of the pH detected at the tip of the gastric tube. The test result is given in binary form: Yes (green signal, probe in stomach) / No (red signal, probe incorrectly positioned).

Study hypothesis and prospects: To make an initial estimate of the sensitivity and specificity of the NGPOD system for checking the positioning of the naso- or oro-gastric tube in the stomach, compared with the recognized gold standard, the chest X-ray.

研究设计

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

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

  • Patient hospitalized in intensive care
  • Patients aged 18 or over with no upper age limit
  • Patients admitted to intensive care with a nasogastric or orogastric tube placed in the operating room (not controlled by radiography) or for whom the placement of a gastric tube in intensive care is indicated.
  • Consent to research participation

排除标准

  • Patients undergoing limitation and discontinuation of active therapies
  • Patients with contraindications to blind gastric tube placement (recent esophageal or gastric surgery, ENT lesions, uncontrolled upper GI bleeding, esophageal or gastric cancer)
  • Patients under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection

研究组 & 干预措施

Patients requiring an orogastric or nasogastric tube

Experimental

干预措施: pH indication with NGPOD (Diagnostic Test)

结局指标

主要结局

Ability of the NGPOD device to detect correct positioning of the gastric tube.

时间窗: Up to one Day

Comparison of NGPOD and chest X-ray results.

次要结局

  • x-ray manipulators time("through study completion, an average of 1 year")
  • Probe malpositioning(Up to one Day)
  • Time to validate correct positioning of gastric tube(Up to one Day)
  • Evaluation of the "simplicity" of the procedures for using and interpreting the NGPOD system(Up to one Day)
  • Adverse events occurring during the study period("through study completion, an average of 1 year")
  • Ability of the NGPOD device to detect correct gastric tube positioning in a subgroup of patients(Up to one Day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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