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临床试验/NCT02635906
NCT02635906已完成不适用

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

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
150
试验地点
1
主要终点
Back Pain, Lumber Pain and Muscle Pain

研究概览

简要总结

This is a randomized clinical trial with a control group, based on the guidelines of the CONSORT 2010. The interventional group will be in a bed rest for two hours after introducer removal in patients submitted a coronary arteriography or coronary angioplasty and the control group will follow the standard nursing care for four hours.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •patients admitted with Acute Coronary Syndrome undergoing coronary arteriography or coronary angioplasty by femoral arterial.

排除标准

  • •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.

研究组 & 干预措施

2 hours

Experimental

after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for two hours

干预措施: 2 hours (Other)

4 hours

Active Comparator

after coronary arteriography or coronary angioplasty, will be removal the introducer and the patient will be in bed rest for four hours

干预措施: 4 hours (Other)

结局指标

主要结局

Back Pain, Lumber Pain and Muscle Pain

时间窗: 1 hour after the bed rest

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.

次要结局

  • Bleeding(24 hours after the coronary angioplasty)
  • Haematoma(24 hours after the coronary angioplasty)
  • Pseudoaneurysm, Arteriovenous Fistula: Retroperitoneal hematoma, Acute Arterial Occlusion:(24 hours after the coronary angioplasty)
  • Urinary retention, Paresthesia(1 hour after the bed rest)

研究者

发起方
Federal University of São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vinicius Batista Santos

Nursing Coordinator

Federal University of São Paulo

研究点 (1)

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