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

Pacemaker Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06330675
• Other study ID #: 2022-01820
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: March 2024
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Elena Caporali, MD
• Phone: +41 (0)91 811 53 24
• Email: elena.caporali[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 558
• Est. completion date: June 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Defibrillators, Implantable
• Pacemaker

Intervention

Other:
• Early mobilization
Short-term bed-rest and immobilization
• Standard of care
Bed-rest and immobility until the day-after procedure

Locations

Country	Name	City	State
Switzerland	Cardiocentro Ticino Institute - EOC	Lugano

Sponsors (2)

Lead Sponsor	Collaborator
Caporali Elena	Cardiocentro Ticino

Country where clinical trial is conducted

Switzerland, 

Outcome

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