Postprocedural Bed-Rest Strategies After Transfemoral Venous Interventions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
The goal of this clinical trial is to determine whether shorter periods of immobilization and bed rest after femoral venous interventional procedures can be safely used in adult patients undergoing peripheral venous interventions through femoral venous access. The main questions it aims to answer are:
1. Do shorter periods of immobilization and bed rest increase the risk of femoral venous access-site bleeding-related complications, including bleeding and hematoma? 2. Can shorter periods of immobilization and bed rest improve patient comfort, reduce back pain and anxiety, and allow earlier mobilization?
Researchers will compare three postprocedural management strategies: 2 hours, 4 hours, and 8 hours of total immobilization and bed rest, to evaluate their safety and effects on patient recovery and comfort.
Participants will be randomly assigned to one of the following three groups:
2-hour group: the puncture-side leg will be kept strictly immobilized for 0.5 hour, followed by 1.5 hours of bed rest.
4-hour group: the puncture-side leg will be kept strictly immobilized for 2 hours, followed by 2 hours of bed rest.
8-hour group: the puncture-side leg will be kept strictly immobilized for 4 hours, followed by 4 hours of bed rest.
During strict immobilization, the puncture-side leg must remain extended and still. During the subsequent bed-rest period, small position adjustments and gentle movements in bed are allowed, but participants may not stand or walk.
Participants will be monitored for puncture-site bleeding and other complications and will complete assessments of comfort, pain, and anxiety after the procedure.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
No clinically significant neurological or cognitive impairment, and no pre-existing condition causing substantial limitation of lower-extremity mobility before the procedure.
Undergoing at least one of the following peripheral venous interventional procedures via femoral venous access, with postprocedural hemostasis achieved by manual compression: Lower-extremity venography alone; Inferior vena cava filter placement; Iliac vein stent placement; Endovascular thrombus removal for lower-extremity deep vein thrombosis; Other peripheral venous interventions using a 5-12 F sheath, including balloon angioplasty alone, pelvic vein embolization, or renal vein stent placement.
Able to understand the purpose and procedures of the study, provide written informed consent, and comply with the study procedures and follow-up.
Disqualifiers
Concomitant ipsilateral femoral arterial access during the index procedure or inadvertent percutaneous puncture of the femoral artery.
Visible access-site hematoma, persistent bleeding or oozing, pseudoaneurysm, or arteriovenous fistula occurring during femoral venous puncture or after sheath removal before randomization.
Requirement for additional non-protocol anticoagulation after the procedure, or any foreseeable condition preventing adherence to the assigned immobilization and bed-rest schedule or completion of the scheduled assessments.
Planned repeat puncture in the femoral region during the observation period or requirement for continued placement of a large-bore vascular sheath.
Trial design
Design model
Parallel
Treatments tested in this trial
2-hour Immobilization and Bed Rest
BehavioralParticipants will undergo 0.5 hour of strict immobilization followed by 1.5 hours of bed rest. During immobilization, the puncture-side lower limb will remain fully extended and still. During subsequent bed rest, small position adjustments and gentle movements in bed are permitted, but standing, weight bearing, and ambulation are not allowed.
4-hour Immobilization and Bed Rest
BehavioralParticipants will undergo 2 hours of strict immobilization followed by 2 hours of bed rest. During immobilization, the puncture-side lower limb will remain fully extended and still. During subsequent bed rest, small position adjustments and gentle movements in bed are permitted, but standing, weight bearing, and ambulation are not allowed.
8-hour Immobilization and Bed Rest
BehavioralParticipants will undergo 4 hours of strict immobilization followed by 4 hours of bed rest. During immobilization, the puncture-side lower limb will remain fully extended and still. During subsequent bed rest, small position adjustments and gentle movements in bed are permitted, but standing, weight bearing, and ambulation are not allowed.
Treatment groups
1,550 Participants
are divided into 3 treatment groupsGroup A: 2-hour groupExperimental treatment 1 intervention
Group B: 4-hour groupExperimental treatment 1 intervention
Group C: 8-hour groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Access-Site Bleeding-Related Complications
Composite incidence of femoral venous access-site bleeding-related complications, including bleeding requiring repeat manual compression and access-site hematoma. Minor oozing requiring dressing change only will not be counted as an event. Hematomas will be assessed by ultrasound whenever feasible, with the maximum size recorded and categorized as \<6 cm or ≥6 cm. Severe access-site complications include retroperitoneal bleeding; imaging-confirmed arteriovenous fistula or pseudoaneurysm; hematoma associated with a hemoglobin decrease ≥2 g/dL; bleeding or hematoma requiring blood transfusion; surgical or interventional radiology treatment; rehospitalization or prolongation of hospitalization by ≥24 hours due to an access-site complication; or symptomatic, imaging-confirmed access-related venous thrombosis.
Time frame
Within 24 hours after the procedureSecondary outcomes
1
General Comfort Questionnaire Score
Participant comfort will be assessed using the Chinese version of the General Comfort Questionnaire (GCQ). The questionnaire contains 30 items covering physical, psychospiritual, sociocultural, and environmental dimensions of comfort. Each item is rated on a 4-point Likert scale, with appropriate reverse scoring for negatively worded items. Total scores range from 28 to 112, with higher scores indicating greater comfort.
Time frame
8 hours after the procedure2
Comfort Numeric Rating Scale Score
Overall comfort will also be assessed using a Numeric Rating Scale (NRS) ranging from 1 to 10. Participants will rate their overall level of comfort, with 1 indicating the lowest level of comfort and 10 indicating the highest level of comfort. Higher scores indicate greater comfort.
Time frame
8 hours after the procedure3
Puncture-Site Pain Score
Puncture-site pain will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Time frame
8 hours after the procedure4
Low Back Pain Score
Low back pain will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity.
Time frame
8 hours after the procedureLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: