Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation

Not Applicable

Recruiting

• Conditions: Defibrillators, Implantable; Pacemaker

• Registration Number: NCT06330675
• Lead Sponsor: Caporali Elena

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-26
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-08
• Last Update Posted: 2025-08-13
• Primary Completion: 2027-02-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 558

Inclusion Criteria

• ≥ 18 years old
• Signed informed consent form
• New permanent pacemaker implantation (PM) or implantable cardioverter-defibrillator (ICD)

Exclusion Criteria

• CIED implants after recent cardiac surgery
• Upgrade or revision of implanted device
• CRT implantation
• Intraoperative complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion	Within 48 hours post operative	Incidence of post-operatory complications (composite endpoint). Non inferiority margin 5%

Secondary Outcome Measures

Name	Time	Method
Post-operative pain	24 hours	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).
Sleep disturbance	The first night after surgery	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).
Number of participants with postoperative urinary retention	Within 24 hours post operative	Number of participants requiring an intervention such as a Foley catheter or catheterization
Number of participants developing postoperative delirium	Within 24 hours post operative	Number of participants who develop postoperative delirium, as assessed by the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM)
Number of participants developing orthostatic intolerance	First out-of-bed mobilization	Number of participants who develop symptoms of orthostatic intolerance such as dizziness, nausea, vomiting, blurred vision, or syncope, during mobilization
Quality of recovery	Day 1	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).
Number of participants developing pressure ulcer	Within 48 hours post operative	Number of participants who develop pressure ulcers, assessed using Pressure Ulcer Classification System (stage 1, stage 2, stage 3, and stage 4)

Trial Locations

Locations (1)

Cardiocentro Ticino Institute - EOC; 🇨🇭 Lugano, Switzerland