NCT05632640

Post Anesthesia Care Unit (PACU) Weighted Blanket Study

Effectiveness of Weighted Blankets to Decrease Emergence Agitation, Sedation, and Vascular Complications in a Pediatric Cardiac Post Anesthesia Care Unit Following Cardiac Catheterization

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate the safety and efficacy of weighted blankets to reduce agitation in patients in the post-procedural phase after cardiac catheterization and electrophysiology procedures in the post anesthesia care unit. The study hypothesizes that compared to the traditional and current post-procedural strategy, weighted blanket use will reduce agitation and therefore lessen the need for additional sedation along with a reduction of post-procedure vascular complications.

Conditions

• Cardiac Catheterization
• Electrophysiology Procedure
• Pediatric Cardiology

Interventions

Type	Name	Description
OTHER	Standard of Care	Following the participants procedure, standard of care will be given in the recovery area.
DEVICE	Weighted blanket	Following the participants procedure once in the recovery area, the nursing staff will place a weighted blanket on the participants. Different weighted blanket sizes will be used based on participants weight.

Timeline

• Start date: 2023-03-08
• Primary completion: 2025-04-22
• Completion: 2025-04-22
• First posted: 2022-11-30
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study