Safety and Benefits of Mobilization at 4 Hours Compared to 24 Hours After Implantation of an Intracardiac Electronic Device: a Randomized Clinical Trial

What this Trial Is About

Researchers are evaluating the safety of early mobilization after implantation of intracardiac electronic devices, such as pacemakers or implantable cardioverter-defibrillators. The study compares mobilization at 4 hours after the procedure to the standard approach of mobilization the day after, aiming to provide guidance on the best timing to prevent complications. This trial is open, randomized, and controlled, focusing on whether early mobilization is not worse than the usual care. Participants are assigned to one of two groups: one with short-term bed-rest and mobilization starting 4 hours after the procedure, and the other following the standard care of bed-rest until the day after the procedure. Both groups undergo implantation of a new permanent pacemaker or defibrillator. The study monitors participants closely for safety and recovery during the first 48 hours after surgery. During the study, participants will be observed for complications such as pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion within 48 hours after the operation. Additional assessments include post-operative pain, sleep disturbance, urinary retention, delirium, orthostatic intolerance, quality of recovery, and pressure ulcers. The total study period includes close monitoring in the immediate postoperative phase to assess the safety and benefits of early versus delayed mobilization.

Correct Mobilization Time After Implantation of an Intracardiac Electronic Device Implantation