Yoğun Bakım Ünitesinde Takip Edilen Hastalarda Gastrik Boşalmanın Abdominal Ultrasonografi Ile Değerlendirilmesi
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Agreement Between Ultrasound and Free Drainage for Gastric Volume Measurements
研究概览
简要总结
This study aims to evaluate the compatibility of gastric volume (GV) measurements obtained through ultrasound with the free drainage method in intensive care patients receiving enteral nutrition under three different protocols. The study seeks to determine the consistency of GV measurements across these protocols to improve patient management in critical care settings.
详细描述
Adult patients hospitalized in intensive care unit due to cerebrovascular disease and receiving mechanical ventilator treatment were included in the study. Patients who were started on semi-solid nutritional solution (standard nutritional products of 1kcal/1 ml according to the comorbidities of the patients) via nasogastric (NG) 14 F polyurethane (PU) feeding catheter (BAXEN Medical, Spain) and reached the full calorie goal for at least 24 hours were included. Full dose calorie calculation of the patients was performed using the Harris-Benedict method (for women: 655.1+(9.56xweight (kg)) -(1.85xheight (cm)) -(4.68xage) for men: 66.5+(13.75xweight (kg)) +(5.03xheight (cm)) -(6.75xage). Feeding tube placement was confirmed with an AP radiograph taken before inclusion in the study.
Patients with shock due to any cause, abdominal surgery, GI bleeding, obstruction, suspected perforation, malabsorption syndrome, prokinetic use or diarrhea, patients with a BMI >35 according to last known height and weight, and pregnant patients (due to inability to achieve right lateral position) were excluded. In addition, patients who could not be imaged, whose feeding protocol was changed and whose vasopressor doses were increased were excluded from the study.
The amount of EN products administered to the patients, age, gender, body weight, height, body mass index (BMI), comorbidities, vasopressor therapy and dose administered during imaging were recorded.
ICU units have a physician-driven nutrition strategy, aiming for an adequate caloric and protein intake. Patients were divided into 3 groups according to implemented nutrition protocols. Ultrasonographic measurements were performed in 24-hour periods after the volume required for the target calorie intake.
Group 1: Patients who received 18 hours of infusion feeding, 6 hours of waiting and one hour of drainage Group 2: Patients who received 5 hours of infusion feeding, 1 hour of waiting and one hour of drainage Group 3: Patients who were fed with continuous infusion for 24 hours and drained for one hour Measurement of gastric volume
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Age Range: Adult patients aged 18 years and older.
- •ICU Admission: The study will include only patients who are currently admitted to the Intensive Care Unit (ICU) due to cerebrovascular diseases
- •Receiving Enteral Nutrition: Patients must be receiving enteral nutrition through one of the three specified protocols.
- •Eligibility for Gastric Volume (GV) Measurement: Patients must be medically eligible for GV measurement via ultrasound.
- •Informed Consent: The patient or their legal representative must provide informed consent to participate in the study.
排除标准
- •Age Below 18: Patients under 18 years of age.
- •Pregnancy: Pregnant patients will be excluded due to potential risks or confounding factors related to pregnancy.
- •Gastrointestinal Surgery History: Patients with a recent history of gastrointestinal surgery, which may affect GV measurements, will be excluded.
- •Contraindications for Ultrasound: Patients with conditions that prevent safe or accurate ultrasound measurement (e.g., severe abdominal wounds or high abdominal obesity) will be excluded.
- •Inability to Tolerate Enteral Nutrition: Patients who are unable to receive enteral nutrition for any reason (e.g., severe intolerance, contraindications) will be excluded.
- •Lack of Informed Consent: Patients or their legal representatives who do not provide informed consent.
结局指标
主要结局
Agreement Between Ultrasound and Free Drainage for Gastric Volume Measurements
时间窗: Gastric volume measurements will be conducted at 24 hours after initiating each enteral nutrition protocol
Gastric volume will be measured in ICU patients using ultrasound imaging and the free drainage method. Agreement between the two methods will be evaluated using Bland-Altman analysis and Intraclass Correlation Coefficients (ICCs). The data will be reported as mean ± standard deviation for continuous variables and proportions for categorical data. Results will be aggregated across the three enteral nutrition protocols.
次要结局
未报告次要终点
研究者
Ilkay Ceylan
MD
Bursa Yüksek İhtisas Education and Research Hospital