Correct Mobilization Time After CIED Implantation: A Single-centre, Open-label, Non-inferiority RCT

Not Applicable

Recruiting

• Conditions: Defibrillators, Implantable; Pacemaker
• Interventions: Other: Early mobilization; Other: Standard of care

• 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
• Status Verified: 2024-03
• Study First Submitted: 2024-03-19
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• 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

Arm && Interventions

Group	Intervention	Description
Mobilization 4-h after procedure	Early mobilization	Short-term bed-rest (4-h) after CIED implantation
Mobilization day-after procedure	Standard of care	Standard of care with prolungate bed-rest after CIED implantation

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
Quality of recovery	Day 1	The score of the Quality of recovery-15 (QoR-15) and subscores.
Delirium	Within 24 hours post operative	The occurence of postoperative delirium using 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM).
Orthostatic intolerance	First out-of-bed mobilization	Symptoms of orthostatic intolerance: dizziness, nausea, vomiting, blurry vision or syncope during mobilization.
Pressure ulcer	Within 48 hours post operative	NPIAP - Pressure Ulcer Classification System (stage1, stage2, stage 3, stage 4)
Post-operative pain	24 hours	Pain is assessed with a numerical rating scale (NRS)
Sleep disturbance	The first night after surgery	Total scores of the Richards-Campbell Sleep Questionnaire, and subscores.
Postoperative urinary retention	Within 24 hours post operative	The absence of voiding naturally needing an intervention as a Foley catheter or a catheterization.

Trial Locations

Locations (1)

Cardiocentro Ticino Institute - EOC; 🇨🇭 Lugano, Switzerland