Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation

ConditionsPacemaker Defibrillators, Implantable

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCaporali Elena

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥ 18 years old

Signed informed consent form

New permanent pacemaker implantation (PM) or implantable cardioverter-defibrillator (ICD)

Disqualifiers

CIED implants after recent cardiac surgery

Upgrade or revision of implanted device

CRT implantation

Intraoperative complications

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

558 Participants

are divided into 2 treatment groups

Group A: Mobilization 4-h after procedureExperimental treatment 1 intervention

Group B: Mobilization day-after procedureActive comparator 1 intervention

Trial outcomes

Primary outcomes

Composite 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

Secondary outcomes

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

Other outcomes

Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection

Number of patients suffering with post-operatory complications

Time frame

3 month

Sponsors and contacts

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Caporali Elena

Lead sponsor

Ente Ospedaliero Cantonale, Bellinzona

Sponsor institution

Cardiocentro Ticino

Collaborator

Source ClinicalTrials.gov

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