A Prospective, Single-Center, Open Label, Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal Tract Using the KANGAROO™ Feeding Tube With IRIS Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- The ability of the clinician to recognize anatomical markers in the gastrointestinal tract using the IRIS feeding tube
研究概览
简要总结
This is a prospective, single-center, open label, within-subject clinical trial to evaluate the identification of anatomical markers in the gastrointestinal tract using the IRIS feeding tube. The trial will evaluate hospitalized subjects who require short-term enteral feeding with an anticipated duration of at least 3 days while in an intensive care unit (ICU) or step-down unit. Eligible men and women at least 18 years of age who give voluntary, written informed consent to participate in the clinical investigation will be included as subjects. If a potential subject is incapacitated and unable to provide informed consent, a designated legally authorized representative will be allowed to provide the informed consent on behalf of the subject to allow their participation in the study. Study entry will be defined as the point of signed informed consent. A Prospective, Single-Center, Open Label, Within-Subject Case Series to Evaluate the Identification of Anatomical Markers in the Gastrointestinal Tract Using the KANGAROO™ Feeding Tube with IRIS Technology
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Hospitalized male and female patients in a monitored setting (i.e.; ICU or Step-Down Unit) who require and are eligible for short-term enteral (nasal or oral) feeding per standard of care with an expected duration of at least 3 days.
- •The subject or a legally authorized representative is able to understand and willing to give written informed consent.
- •Be a man or woman of 18 years or older
- •Have uncomplicated naso- and oropharyngeal anatomy based upon a focused physical examination
排除标准
- •Women and men under the age of 18 years
- •Female patients who are known to be pregnant or lactating
- •Incarcerated or imprisoned individuals
- •Hemodynamic instability with an inability to maintain a MAP > 65 mm Hg on vasopressors
- •Patients who are currently enrolled in an investigational or interventional drug or device clinical trial
- •Patients who have been previously enrolled into this study
- •Individuals, who, in the opinion of the Principal Investigator, have any medical, social or psychological condition that would compromise their participation and follow-up in this clinical investigation
- •Known basal skull fractures
- •Unrepaired known GI perforation or leak
- •Recent adequate upper GI bleed that may obscure images
- •Esophageal varices > Grade 2
- •Subjects with known anomalies precluding gastric or intestinal insertion (via either nasally or orally)
- •Known obstruction of the gastrointestinal tract
- •Known bowel ischemia or any other contraindication for enteral feeding
结局指标
主要结局
The ability of the clinician to recognize anatomical markers in the gastrointestinal tract using the IRIS feeding tube
时间窗: during the feeding tube placement procedure
the following anatomical structures will be noted if visualized and the depth of feeding tube will also be recorded corresponding to the visualized structure: trachea/carina, esophagus, stomach
次要结局
未报告次要终点