Randomized Clinical Trial to Assess the Safety of Reducing the Time of Bed Rest Within Five to Three Hours After Diagnostic Cardiac Catheterization With a 6F Sheath
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 730
- 试验地点
- 2
- 主要终点
- Safety
研究概览
简要总结
Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours.
详细描述
Reducing the rest time after diagnostic cardiac catheterization for three hours does not increase the complications concerning to the procedure, compared to the rest of five hours. The aim of this study is to compare through a randomized clinical trial to reduce the rest time in bed for five hours after elective diagnostic cardiac catheterization, with a 6F sheath with a transfemoral approach, for a period of three hours of the occurrence of bleeding, hematoma, pseudoaneurysm and a vasovagal reaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •age equal too or above 18 years
- •patients undergoing elective diagnostic cardiac catheterization on an outpatient basis and
- •who agree to participate by reading and signing the informed consent form.
排除标准
- •patients with restriction ambulation;
- •users of coumarin anticoagulants;
- •IMC greater than 35 kg/m2;
- •patients with hypertension (systolic PA > 180 mmHg and diastolic PA > 110 mmHg) at the end of the procedure
结局指标
主要结局
Safety
时间窗: until three days
Bleeding: seen after the femoral compression after walking and after sitting down ;Hematoma, pseudoaneurysm and bruise: at the site of arterial puncture;vaso-vagal reaction. All of these will be monitoring by telephone contact at 24h, 48h and 72 hours.
次要结局
未报告次要终点
研究者
Eneida Rejane Rabelo da Silva
Professor, ScD
Hospital de Clinicas de Porto Alegre