Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
558
Short-term bed-rest and immobilization
Bed-rest and immobility until the day-after procedure
Cardiocentro Ticino Institute - EOC
Lugano, Switzerland
RECRUITINGComposite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion
Incidence of post-operatory complications (composite endpoint). Non inferiority margin 5%
Time frame: Within 48 hours post operative
Post-operative pain
Pain will be assessed with the Numerical Rating Scale (NRS) scale ranging from 0 to 10 (0 corresponds to no pain and 10 to maximal level of pain).
Time frame: 24 hours
Sleep disturbance
Quality of sleep will be assessed using the Richards-Campbell Sleep Questionnaire (RCSQ), which ranges from 0 to 500 points, where 0 indicates the worst possible sleep quality and 500 the best possible. The sub-scores include sleep depth, sleep latency, number of awakenings, return to sleep after awakening, and overall sleep quality (each ranging from 0 to 100 points).
Time frame: The first night after surgery
Number of participants with postoperative urinary retention
Number of participants requiring an intervention such as a Foley catheter or catheterization
Time frame: Within 24 hours post operative
Number of participants developing postoperative delirium
Number of participants who develop postoperative delirium, as assessed by the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
Time frame: Within 24 hours post operative
Number of participants developing orthostatic intolerance
Number of participants who develop symptoms of orthostatic intolerance such as dizziness, nausea, vomiting, blurred vision, or syncope, during mobilization
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Time frame: First out-of-bed mobilization
Quality of recovery
Quality of recovery assessed with the Quality of recovery-15 (QoR-15) ranging from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery), and sub-scores (physical comfort 0-50, emotional state 0-40, psychological support 0-20, physical independence 0-20 and pain 0-20).
Time frame: Day 1
Number of participants developing pressure ulcer
Number of participants who develop pressure ulcers, assessed using Pressure Ulcer Classification System (stage 1, stage 2, stage 3, and stage 4)
Time frame: Within 48 hours post operative