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

Safety and Benefits of Mobilization at 4 Hours Compared to 24 Hours After Implantation of an Intracardiac Electronic Device: a Randomized Clinical Trial of Non-inferiority, Open and Controlled in Parallel Groups

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 Overview

• Status: Recruiting
• Conditions: Defibrillators, Implantable; Pacemaker
• Intervention / Treatment: Other: Early mobilization; Other: Standard of care

• Study Type: Interventional
• Enrollment (Estimated): 558
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elena Caporali, MD; Phone Number: +41 (0)91 811 53 24; Email: elena.caporali@eoc.ch
• Study Contact Backup: Name: Michele Villa, RN; Phone Number: +41 (0)91 811 50 59; Email: michele.villa@eoc.ch

Study Locations

• Switzerland
  • Lugano, Switzerland, 6900
    • Recruiting
    • Cardiocentro Ticino Institute - EOC
    • Contact: Elena Caporali, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobilization 4-h after procedure; Short-term bed-rest (4-h) after CIED implantation	Other: Early mobilization; Short-term bed-rest and immobilization
Active Comparator: Mobilization day-after procedure; Standard of care with prolungate bed-rest after CIED implantation	Other: Standard of care; Bed-rest and immobility until the day-after procedure

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection	Incidence of post-operatory complications	3 month

Collaborators and Investigators

• Sponsor: Caporali Elena
• Collaborators: Cardiocentro Ticino
• Investigators: Principal Investigator: Elena Caporali, MD, Cardiocentro Ticino Institute - EOC

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: March 19, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pacemaker; Early mobilization; Implantable cardioverter-defibrillator; Bed-rest
• Other Study ID Numbers: 2022-01820

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No