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| Name | Class |
|---|---|
| Cardiocentro Ticino | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobilization 4-h after procedure | Experimental | Short-term bed-rest (4-h) after CIED implantation |
|
| Mobilization day-after procedure | Active Comparator | Standard of care with prolungate bed-rest after CIED implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early mobilization | Other | Short-term bed-rest and immobilization |
| |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 24 hours |
| Sleep disturbance |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of pacing lead dislodgement, pocket hematoma, pneumothorax, pericardial effusion, and pocket infection | Number of patients suffering with post-operatory complications | 3 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elena Caporali, MD | Contact | +41 (0)91 811 53 24 | elena.caporali@eoc.ch | |
| Michele Villa, RN | Contact | +41 (0)91 811 50 59 | michele.villa@eoc.ch |
| Name | Affiliation | Role |
|---|---|---|
| Elena Caporali, MD | Cardiocentro Ticino Institute - EOC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiocentro Ticino Institute - EOC | Recruiting | Lugano | 6900 | Switzerland |
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| ID | Term |
|---|---|
| D004434 | Early Ambulation |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| Standard of care |
| Other |
Bed-rest and immobility until the day-after procedure |
|
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).
| 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 | 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) | Within 24 hours post operative |
| Number of participants developing orthostatic intolerance | Number of participants who develop symptoms of orthostatic intolerance such as dizziness, nausea, vomiting, blurred vision, or syncope, during mobilization | First out-of-bed mobilization |
| Quality of recovery | 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). | Day 1 |
| Number of participants developing pressure ulcer | Number of participants who develop pressure ulcers, assessed using Pressure Ulcer Classification System (stage 1, stage 2, stage 3, and stage 4) | Within 48 hours post operative |
| D013812 |
| Therapeutics |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |