Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty
Effectiveness of Reduced in Bed Rest After Coronary Arteriography or Coronary Angioplasty in Patients With Acute Coronary Syndrome: 4 Hours Versus 2 h.Clinical Trial
研究概览
详细说明
This is a randomized clinical trial with a control group, based on the guidelines of the CONSORT 2010. It will be held in the cardiology unit of a public hospital in the city of São Paulo in patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial. Patients with hemodynamic instability will be excluded before and after the ATC, patients using oral anticoagulants presenting INR greater than 2; patients using inhibitors IIB / IIIa; patients with history of blood dyscrasias; patients undergoing invasive procedure again less than 24 hours; patients with previous diagnosis of arterial insufficiency and patients at the time of withdrawal of the introducer presenting systolic blood pressure greater than 180 mmHg and diastolic than 100 mmHg. After removing the introducer the interventional group will be in a bed rest for two hours and the control group will follow the standard nursing care for four hours. Will be assessed the following indicators: bruising, bleeding, pedis pulse and popliteal, presence of blast at the puncture site after removal of the introducer, peripheral perfusion, presence of pulsatile mass, back pain, low back pain, paresthesias, urinary retention, muscle aches, use of painkillers and erythrocyte level.
These indicators will be assessed prior to the procedure, immediately after removing the introducer, 6 hours after the removal of the introducer, 12 hours after removal of the introducer and 24 hours after removal of the introducer. Vascular outcomes will be considered the appearance of bruising, bleeding, pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma and acute arterial occlusion. Related to patient outcomes will be considered the complaints back pain, back pain, muscle pain, paresthesia and urinary retention. The assessment team will be composed of three nurses specialists in cardiology with a minimum of one year experience in patient care after the ATC. For this study will be presented by the principal investigator to the patient the study objectives, possible risks and complications and the study protocol, and if the patient agrees to participate in it will be delivered the Statement of Consent. The collected data regarding the patients included in the survey will be entered initially in a Microsoft Excel® 2010 software and later transferred to an electronic database software SPSS (Statistical Package for Social Sciences) version 20.0 and, then submitted to descriptive statistical analysis and comparison analysis between groups.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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São Paulo、巴西、04024-002
- Hospital São Paulo - Cardiology Unit
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial.
Exclusion Criteria:
- patients with hemodynamic instability will be excluded before and after the ATC,
- patients using oral anticoagulants presenting INR greater than 2;
- patients using inhibitors IIB / IIIa;
- patients with history of blood dyscrasias;
- patients undergoing invasive procedure again less than 24 hours;
- patients with previous diagnosis of arterial insufficiency.
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:2 hours
after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for two hours
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BED REST FOR TWO HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
其他名称:
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有源比较器:4 hours
after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for four hours
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BED REST FOR FOUR HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Back Pain, Lumber Pain and Muscle Pain
大体时间:1 hour after the bed rest
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This outcome will be measured in relation to presence or absence.
The presence and will Assess by means of a visual analog scale of 0 to 10, whereas the smallest value as no pain and the largest value as unbearable pain.
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1 hour after the bed rest
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Haematoma
大体时间:24 hours after the coronary angioplasty
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This outcome will be measured in relation to presence or absence.
The presence and will measured with a millimeter ruler taking.
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24 hours after the coronary angioplasty
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Bleeding
大体时间:24 hours after the coronary angioplasty
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This outcome will be measured when appear blood in a bandage or when the haemoglobin decrease more than 3g/d.
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24 hours after the coronary angioplasty
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Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:
大体时间:24 hours after the coronary angioplasty
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This outcome will be measured in relation to presence or absence by ultrasound.
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24 hours after the coronary angioplasty
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Urinary retention, Paresthesia
大体时间:1 hour after the bed rest
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This outcome will be measured in relation to presence or absence.
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1 hour after the bed rest
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合作者和调查者
调查人员
- 学习椅:VINICIUS B SANTOS, MASTER、Federal University of São Paulo
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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