A Study of Modified Limb Braking and Early Bed Mobility Strategies After Femoral Venipuncture Intervention
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Degree of postoperative bleeding
研究概览
简要总结
The goal of this clinical trial is to compare in describe participant population health conditions. The main questions it aims to answer are:
- To obtain the limb movement and bed mobility limits after femoral venipuncture, in order to provide a basis and support for clinical reduction of postoperative braking time and alleviation of postoperative patient subjective discomfort
- To analyze the effect of perioperative factors such as anticoagulation and sheath size on the complication rate, so as to develop a detailed and systematic strategy to stop bleeding after femoral venipuncture
- The advantages and necessity of reducing the postoperative braking time in bed were demonstrated by objective evaluation of patients' postoperative subjective feelings and mental status.
In this prospective study, 150 patients who underwent femoral vein puncture intervention were selected by inclusion and exclusion criteria, and were randomly divided into control group, trial A group and trial B group by SPSS software, with 50 cases each. In the control group, the lower limb of the punctured side was braked for 4 hours + 8 hours after routine postoperative activities; in the trial A group, the lower limb of the punctured side was braked for 2 hours + 4 hours after postoperative activities; in the trial B group, the lower limb of the punctured side was braked for no postoperative activities + 2 hours after postoperative activities, and the corresponding evaluation indexes and questionnaires were used to record the hemostasis at the puncture site, whether complications occurred and the subjective feelings of patients in each group after completing the corresponding strategies. The data were also recorded along with the general information of the patients and the factors that may cause bleeding in the perioperative period. Statistical analysis was used to classify, summarize and draw conclusions about the data obtained, analyze the limit of braking bed time, and formulate scientific hemostatic strategies.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-75 years old, no serious liver or kidney function abnormalities.
- •No significant preoperative bleeding tendency or hemostatic dysfunction, platelets ≥75×109/L, prothrombin time (PT) <16 s.
- •No other femoral vascular puncture procedures were performed bilaterally during the observation period.
- •Normal neurological and cognitive function, able to make a correct assessment, able to move normally on the floor after surgery, informed consent and willing to cooperate.
排除标准
- •Patients in whom this operation is combined with ipsilateral femoral artery puncture or intraoperative percutaneous puncture into the femoral artery by mistake.
- •Patients with significant hematoma during femoral vein puncture or with the formation of a visually visible hematoma at the puncture site after removal of the sheath or persistent blood leakage, pseudoaneurysm, or arteriovenous fistula.
- •Patients with severe insufficiency of important organs or obvious hemostasis and coagulation dysfunction.
- •Patients with poor postoperative compliance or other insurmountable reasons for inability to complete the prescribed time of activity and get out of bed.
- •Patients who are unwilling to sign the informed consent form after being adequately informed by the investigator about the trial.
研究组 & 干预措施
Control group
Lower extremity on the puncture side with a 4-hour brake+Get out of bed after 8 hours
Test group A
Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours
干预措施: Reduced postoperative braking and bed rest time.Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours (Other)
Test group B
No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours
干预措施: Significantly reduce postoperative braking and bed rest time.No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours (Other)
结局指标
主要结局
Degree of postoperative bleeding
时间窗: 8 hours after surgery
he Christenson modification method \[13 was applied to classify the degree of bleeding into normal, non-significant bleeding, and significant bleeding. (1) Normal: no visible bloody exudate on the dressing; (2) Non-significant bleeding: a small amount of localized bleeding, no palpable hematoma or hematoma \<5 cm, no special treatment required; (3) Significant bleeding: more bleeding from the dressing, estimated bleeding volume \>100 ml, hematoma and skin petechiae \>5 cm in diameter, hematoma compression affecting dorsalis pedis artery pulsation, requiring manual compression, sandbag compression or re Compression dressing
次要结局
- Postoperative pain level(6 hours after surgery)
- Postoperative anxiety level(6 hours after surgery)
- Postoperative comfort level(6 hours after surgery)
研究者
Tong Zhu
Chief physician，Professor
Xuanwu Hospital, Beijing