Effect of Position Change and Back Massage Versus Early Ambulation on Post Transfemoral Coronary Angiography Complications
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Ecchymosis and hematoma formation scale
研究概览
简要总结
The study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications.
详细描述
Post transfemoral coronary angiography (TFCA) may be associated with complications such as oozing, bleeding, ecchymosis, hematoma, and back pain. As a result, nursing practice must be geared toward enhancing patient safety post-transfemoral coronary angiography procedure. This study aimed to assess the effect of position change and back massage versus early ambulation on post transfemoral coronary angiography complications. A quasi-experimental research design was used to conduct this study at the Coronary Care Unit of the selected university hospital in Egypt. A convenience sample of 185 patients undergoing transfemoral coronary angiography was included in the study during the first 6 hours post-transfemoral coronary angiography and randomly assigned to two groups: 92 patients received position change and back massage (PCBM group), and 93 patients underwent early ambulation after the first 3 hours post-transfemoral coronary angiography (EA group). The used tool was "Post Transfemoral Coronary Angiography Complication Assessment".
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mean arterial blood pressure ≥70 mmHg.
- •Heart rate ≥ 60 b/m.
- •Manual compression closure technique on the access site
- •Partial thromboplastin time < 90 seconds.
- •Prothrombin time <16 seconds).
- •No anticoagulant therapy within 24 hours before the cardiac catheterization procedure.
排除标准
- •Patients who had a history of previous coronary stents.
- •chronic pain,
- •chronic obstructive pulmonary disease.
- •Renal failure,
- •Hypercoagulable conditions such as protein C.
- •Cardiopulmonary resuscitation during angiography.
- •Femoral artery ruptures during angiography.
- •Chest pain with new electrocardiograph change.
研究组 & 干预措施
Position change and back massage group
The patients received changing of position every two hours as follows in the same order: supine position with a head angle of 15°, semi-fowler position with a head angle of 30°, lateral right or left position with a head angle of 15°. Also, the patients received a simple stroke of lower back massage for 5 minutes every 2 hours
干预措施: Position change and back massage (Other)
Early ambulation
The patient are allowed to ambulate after 3 hours of complete bed rest in the supine position with a zero head of bed elevation angle.
干预措施: Early ambulation (Other)
结局指标
主要结局
Ecchymosis and hematoma formation scale
时间窗: After six hours post transfemoral coronary angiography
It was designed to measure ecchymosis and hematoma size. It classified ecchymosis and hematoma according to the surface area of blood collection under the skin into three items: (1) No ecchymosis or hematoma (no blood collection), (2) Ecchymosis (surface area \<2cm2), (3) Hematoma (surface area ≥ 2cm2). The researcher rated vascular complications on a dichotomous scale (Yes/No). The "Yes" response indicated the presence of complications and was given a score of one. On the other hand, the "No" response indicated the absence of complications and received a score of zero.
Oozing and bleeding scale
时间窗: After six hours post transfemoral coronary angiography
It was designed to measure any leakage of blood from the puncture site. It classified oozing and bleeding according to the surface area of the dressing soaked with blood to three items: (1) No bleeding or oozing (dry dressing), (2) Oozing (surface area \< 2cm 2), (3) Bleeding (surface area ≥2cm 2). The researcher rated vascular complications on a dichotomous scale (Yes/No). The "Yes" response indicated the presence of complications and was given a score of one. On the other hand, the "No" response indicated the absence of complications and received a score of zero.
Numeric rating scale
时间窗: After six hours post transfemoral coronary angiography
The scale was used to assess the lower back pain intensity. It is a four-point numerical rating scale: no pain (0), mild pain (1-3), moderate pain (4-7), severe pain (8-10).
次要结局
未报告次要终点
研究者
Suad Elsaman
Assistant professor
Alexandria University