Tracheal etCO2 Level and Gastric pH Level Measurements During the Correct Naso-gastric Tube Placement in Unconscious Patients. A Physiological, Prospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- pH
研究概览
简要总结
The laying of a naso-gastric tube is an extremely common event in intensive medicine; although standard naso-gastric tube laying is performed at the patient's bedside, this procedure is not without risk. Through the use of methods already used in the clinical field, of daily use, we want to identify the threshold value between tracheal and esophageal etCO2 (group A) and the threshold value between gastric and esophageal pH (group B).
详细描述
Numerous methodologies have been evaluated to recognize the correct positioning of NGT at the gastric level, including different clinical techniques (such as gastric auscultation, aspiration of the NGT), ultrasound techniques, etc. Actually, the diagnostic gold standard is the thoraco-abdominal anterior-posterior radiography, which is considered the only non-invasive method capable to confirm the correct pose of the NGT at intra-diaphragmatic level. This method, however, even if it is non-invasive, requires the use of ionizing radiation (4 micro-Sievert (uSv) for radiography) which could be repeated multiple time for the same patient; NGT may need to be repositioned several times during the same hospital stay, increasing patient exposure to ionizing radiation and, potentially, also the health workers exposure.
The aim is to identify into the group A the threshold value between tracheal and esophageal etCO2 and into the group B the theshold value between gastric and esophageal pH.
Phase A: etCO2 measurement will be collected 1. after intubation, when the tube is inserted into the endotracheal tube, before proceeding with the aspiration of secretions and 2. once the NGT has been inserted, by a probe located at the end of the tube.
Phase B: pH measurement will be collected at the end of the procedure, once the NGT is inserted, at 1.a distance of 25 cm from the mouth (oesophageal site) and at 2. a distance of 40 cm (gastric site), aspirating the gastric contents and measuring on specific litmus paper.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
pH
时间窗: 30-60 seconds
to find a threshold value of pH collected when the NGT is positioned in the esophagus and in the stomach.
etCO2 level
时间窗: 30-60 seconds
to find a threshold value of etCO2 collected when the NGT is well positioned in trachea
次要结局
- etCO2 level in chronic obstructive pulmonary disease (COPD) patients(30-60 seconds)
- pH in patients taking proton pump inhibitors (PPIs)(30-60 seconds)
研究者
Samuele Ceruti
Principal Investigator
Clinica Luganese Moncucco
