Clinical trial NCT05900622: A Study of Modified Limb Braking and Early Bed Mobility Strategies After Femoral Venipuncture Intervention
Official title: A Study of Modified Limb Braking and Early Bed Mobility Strategies After Femoral Venipuncture Intervention
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Deep Vein Thrombosis
Deep Venous Insufficiency
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Degree of postoperative bleeding
timeFrame: 8 hours after surgery
Secondary outcomes:
measure: Postoperative pain level
timeFrame: 6 hours after surgery
measure: Postoperative anxiety level
timeFrame: 6 hours after surgery
measure: Postoperative comfort level
timeFrame: 6 hours after surgery
Other outcomes:
Locations:
Study officials:
References: