Comparison Of Safety And Clinical Outcomes Of Sedated And Unsedated Percutaneous Endoscopic Gastrostomy Procedures İn ASA IV Elderly Patients: A Prospective Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 主要终点
- Incidence of cardiopulmonary complications within 24 hours after PEG placement
研究概览
简要总结
This prospective observational cohort study aims to compare the safety and clinical outcomes of sedated and unsedated percutaneous endoscopic gastrostomy procedures in elderly patients classified as ASA IV. The primary outcome is the development of cardiopulmonary complications within the first 24 hours after the procedure. Secondary outcomes include technical success, procedure duration, early procedure-related complications, length of hospital stay, intensive care requirement, 30-day mortality, and 30-day readmission.
详细描述
Percutaneous endoscopic gastrostomy is commonly used to provide long-term enteral nutrition in patients who are unable to maintain adequate oral intake. Elderly patients with severe systemic disease and high anesthetic risk may be vulnerable to sedation-related cardiopulmonary adverse events. In some clinical settings, PEG can be performed using topical pharyngeal anesthesia and local anesthesia without systemic sedation.
This study will prospectively include elderly ASA IV patients undergoing PEG placement in routine clinical practice. Patients will be categorized into two cohorts according to the sedation strategy used during the procedure: unsedated PEG and sedated PEG. The sedation strategy will not be assigned by the investigators and will be determined according to routine clinical assessment, patient condition, and anesthesiology evaluation when required.
The study will compare cardiopulmonary complications within 24 hours, technical success, procedure-related complications, and 30-day clinical outcomes between the two cohorts.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indications for percutaneous endoscopic gastrostomy for long-term enteral nutrition.
- •Patients who have provided written informed consent from the patient or their legally authorized representative.
- •Those with an Anesthesia Score of ASA 4.
排除标准
- •Need for emergency PEG placement;
- •International normalized ratio (INR) greater than 1.5;
- •Platelet count less than 50,000/mm³;
- •Severe ascites,
- •Active peritonitis; pregnancy;
- •Refusal to participate in the study.
研究组 & 干预措施
Sedated PEG
Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy under sedation as part of routine clinical practice. Sedative agents may include propofol, midazolam, and/or opioid agents according to clinical and anesthesiology evaluation.
Unsedated PEG
Elderly ASA IV patients undergoing percutaneous endoscopic gastrostomy with topical pharyngeal anesthesia and local anesthesia, without systemic sedative medication.
结局指标
主要结局
Incidence of cardiopulmonary complications within 24 hours after PEG placement
时间窗: Within 24 hours after PEG placement
Cardiopulmonary complications will be assessed as a composite outcome including the occurrence of at least one of the following events within the first 24 hours after PEG placement: hypoxemia defined as SpO₂ \<90%, hypotension defined as mean arterial pressure \<65 mmHg, bradycardia defined as heart rate \<50 beats/min, aspiration, need for endotracheal intubation, or intensive care unit admission/transfer.
次要结局
未报告次要终点
研究者
Hilmi Bozkurt
Associate Professor of General Surgery
Mersin University