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

Primary Purpose

Deep Vein Thrombosis, Deep Venous Insufficiency

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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
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
Sponsored by
Tong Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Deep Vein Thrombosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Experimental

    Experimental

    Arm Label

    Control group

    Test group A

    Test group B

    Arm Description

    Lower extremity on the puncture side with a 4-hour brake+Get out of bed after 8 hours

    Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours

    No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    May 23, 2023
    Last Updated
    June 9, 2023
    Sponsor
    Tong Zhu
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05900622
    Brief Title
    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

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    June 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Tong Zhu

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Deep Vein Thrombosis, Deep Venous Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Lower extremity on the puncture side with a 4-hour brake+Get out of bed after 8 hours
    Arm Title
    Test group A
    Arm Type
    Experimental
    Arm Description
    Lower extremity on the puncture side with a 2-hour brake+Get out of bed after 4 hours
    Arm Title
    Test group B
    Arm Type
    Experimental
    Arm Description
    No braking of the lower limb on the side of the puncture+Get out of bed after 2 hours
    Intervention Type
    Other
    Intervention Name(s)
    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
    Intervention Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    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
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Degree of postoperative bleeding
    Description
    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
    Time Frame
    8 hours after surgery
    Secondary Outcome Measure Information:
    Title
    Postoperative pain level
    Description
    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.
    Time Frame
    6 hours after surgery
    Title
    Postoperative anxiety level
    Description
    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.
    Time Frame
    6 hours after surgery
    Title
    Postoperative comfort level
    Description
    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.
    Time Frame
    6 hours after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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