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Recruiting
NCT05632640
Post Anesthesia Care Unit (PACU) Weighted Blanket Study
Conditions: Cardiac Catheterization, Electrophysiology Procedure, Pediatric Cardiology
Sex: All
Ages: 3 Years – 17 Years
Phase: NA
Enrollment: 120
Sponsor: University of Michigan
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Patients undergoing cardiac catheterization or electrophysiology procedurePost Procedure bedrest plan for greater than (>)2 hoursDuration of recovery planned for 11th floor cardiac PACUExclusion Criteria:Patients less than (<) 40 pounds (18 kilogram (kg))Patients > 220 pounds (100 kg)Recovery anticipated to not be in our cardiac PACUPosttraumatic stress disorderClaustrophobiaUncontrolled seizure disordersOpen heart surgery within 30 daysSevere pulmonary hypertensionSevere asthmaSleep apnea requiring continuous positive airway pressure (CPAP)Known diaphragm paresisHome vent/CPAPRestrictive lung disease (such as patients with scoliosis)Higher risk for upper respiratory airway occlusion (such as patients with Down Syndrome)Cast, brace or splint, fracturesDegenerative muscular disorder (such as patients with cerebral palsy)Areas of impaired skin integrityGastrostomy tubePercutaneous endoscopic gastrostomyTracheostomyChest tube(s)PACU procedures required (within 1 hour post arrival): post operative (post op) echocardiogram, post op Xray, post op electrocardiogram
Source: ClinicalTrials.gov (NCT05632640). StuddyBuddy aggregates publicly available trial information.