The Value of Integrated Pulmonary Index Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- Integrated pulmoner index and puls oxymetry
研究概览
简要总结
Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation procedures and can provide early warning during cardiorespiratory derangements.The aim of the study is to determine whether the Integrated Pulmonary Index (IPI) detects changes in ventilation status early in patients undergoing gastrointestinal endoscopy under sedation, and to determine the risk factors affecting hypoxia and severe hypoxia.
详细描述
A single-center and retrospective study was conducted in 154 patients who underwent upper and lower gastrointestinal system endoscopy in the endoscopy unit between October 2018 and December 2019. Patients who were monitored by capnograph in addition to routine monitoring (ECG, noninvasive blood pressure and pulse oximetry monitoring) during the procedure in the endoscopy unit were included in the study.
Patients were administered 2 mg midazolam as premedication for 5 minutes before the procedure and propofol 1-1.3 mg/kg bolus for sedation, followed by repeated doses (10-30 mg) according to the Ramsey sedation score. All patients were given 2 lt/min oxygen via nasal cannula during the procedure. In pulse oximetry, oxygen saturation longer than 15 seconds was defined as less than 92% hypoxia, and below 85% was defined as severe hypoxia.
IPI value was measured with Smart Capnography™, Microstream® Integrated Pulmonary Index device. According to the capnographic information obtained from the patients and preserved in the capnograph disc memory, the planned findings in the study are as follows:
- Number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds)
- Number of severe hypoxic events observed in patients (SaO2 value below 85%)
- Apnea episodes observed in patients (observation of a straight line longer than 15 seconds on the capnograph, absence of respiratory activity)
- Time from apnea to development of hypoxia and severe hypoxia in patients who develop hypoxia and severe hypoxia following apnea
- Time between IPI=1, IPI<7, EtCO2=0 and hypoxia and severe hypoxia.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients monitored by capnograph
- •ASA I-III
- •Patients who underwent an elective endoscopic procedure
排除标准
- •Patients who do not have capnograph monitoring or whose capnography records are missing
- •Emergency endoscopic intervention (GIS bleeding, trauma, etc.)
- •Patients with pre-procedure SaO2 value below 90%, systolic blood pressure below 90 mmHg, heart rate below 50 beats/minute
结局指标
主要结局
Integrated pulmoner index and puls oxymetry
时间窗: From the time between first sedative medication administration to the end of the procedure.
The number of hypoxic events observed in patients (SaO2 value below 92% over 15 seconds) and number of severe hypoxic events observed in patients (SaO2 value below 85%)
次要结局
未报告次要终点
研究者
Hale Kefeli Celik
Principal Investigator, Anesthesiologist
Samsun Education and Research Hospital