Defibrillators, Implantable, Pacemaker
Conditions
Keywords
Pacemaker, Implantable cardioverter-defibrillator, Early mobilization, Bed-rest
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.
Interventions
OTHEREarly mobilization
Short-term bed-rest and immobilization
OTHERStandard of care
Bed-rest and immobility until the day-after procedure
Sponsors
Cardiocentro Ticino
Caporali Elena
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection | 3 month | Number of patients suffering with post-operatory complications |
Countries
Switzerland
Contacts
Primary ContactElena Caporali, MD
Backup ContactMichele Villa, RN
Outcome results
None listed