A Study of Modified Limb Braking and Early Bed Mobility Strategies After Femoral Venipuncture Intervention

Deep Vein Thrombosis Clinical Trial

Official title:

A Study of Modified Limb Braking and Early Bed Mobility Strategies After Femoral Venipuncture Intervention

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05900622
• Other study ID #: [2023]23th
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: June 2024

Study information

• Verified date: June 2023
• Source: Xuanwu Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: June 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Insufficiency
• Venous Thrombosis

Intervention

Other:
• 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
Braking time is defined as the time from the start of postoperative lying down until the patient sits up in bed and can move the lower limbs Bed rest is the time from when the patient is lying down to when they are on the floor after the procedure, but it has been identified as the most difficult part of post-vascular puncture intervention care
• 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
Braking time is defined as the time from the start of postoperative lying down until the patient sits up in bed and can move the lower limbs Bed rest is the time from when the patient is lying down to when they are on the floor after the procedure, but it has been identified as the most difficult part of post-vascular puncture intervention care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tong Zhu

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of postoperative bleeding	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	8 hours after surgery
Secondary	Postoperative pain level	The numeric rating scale (NRS) was used to assess the pain level of each group of patients from 4 to 6 h after surgery. 0 indicates no pain, 1 to 3 indicates mild pain, 4 to 6 indicates moderate pain, 7 to 9 indicates severe pain, and 10 indicates severe pain, which was rated by patients based on subjective feelings.	6 hours after surgery
Secondary	Postoperative anxiety level	The Hamilton Anxiety Scale (HAMA) was used to assess the anxiety level of each group of patients at 4-6 h postoperatively. A HAMA score of <7 indicates no anxiety, =7 indicates possible anxiety, =14 indicates definite anxiety, =21 indicates definite significant anxiety, and =29 indicates severe anxiety.	6 hours after surgery
Secondary	Postoperative comfort level	The kolcaba Comfort Questionnaire (GCQ) was used to assess the comfort level of each group of patients at 4-6 h postoperatively. The higher the GCQ score, the better the comfort level.	6 hours after surgery