Effects of Malnutrition on Respiratory and Renal Functions in Patients Undergoing Peroral Endoscopic Myotomy (POEM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- cardiorespiratory advers events
研究概览
简要总结
The hypothesis of this study is to investigate cardiorespiratory and renal complications in patients under general anesthesia undergoing POEM surgery.
详细描述
The primary purpose of this study is to define mild, medium and severe risk groups for malnutrition by using preoperative albumin values and MUST score in achalasia patients planned for POEM operation, and to determine the relationship of malnutrition/degree as well as demographic characteristics and comorbidities with postoperative respiratory and renal complications.
The secondary aim of this study was to determine persistent respiratory and renal outcome at 3 months after POEM procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria for inclusion in the study:
- •Patients diagnosed with achalasia and suitable for POEM treatment by gastroenterology physicians
- •Between the ages of 18-80
排除标准
- •Criteria for exclusion from the study:
- •Those with a known history of active lung infection, advanced COPD, or respiratory failure
- •Patients with EF below 40%, severe ischemic heart failure, presence of valve disease
- •Those with bleeding diathesis and severe thrombocytopenia (limit 30-50 thousand)
- •severe kidney dysfunction
- •In the presence of known intolerance or allergy to certain medications for sedation, analgesia, or both
- •Pre-existing increased intracranial pressure
- •Having a BMI >30
- •Severe uncorrected hypovolemiaHistory of radiotherapy to the esophagus
- •History of mucosal resection or ablation in the area where POEM will be applied
- •Presence of cirrhosis and portal hypertension.
结局指标
主要结局
cardiorespiratory advers events
时间窗: up to 12 weeks
hypercapnia (above 45mmHg)
postoperative renal complications
时间窗: up to 12 weeks
serum creatinine 0.3 mg/dL rise
次要结局
- Malnutrition condition(up to 12 weeks)
- escart score(up to 12 weeks)
研究者
Zeliha Alicikus
Chief Anesthesiologist
Umraniye Education and Research Hospital