Post Anesthesia Care Unit (PACU) Weighted Blanket Study

University of Michigan

Status: Completed

Conditions: Cardiac Catheterization; Pediatric Cardiology; Electrophysiology Procedure

Treatments: Device: Weighted blanket; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05632640

HUM00215568

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing cardiac catheterization or electrophysiology procedure
• Post Procedure bedrest plan for greater than (>)2 hours
• Duration of recovery planned for 11th floor cardiac PACU

Exclusion criteria

• Patients less than (<) 40 pounds (18 kilogram (kg))
• Patients > 220 pounds (100 kg)
• Recovery anticipated to not be in our cardiac PACU
• Posttraumatic stress disorder
• Claustrophobia
• Uncontrolled seizure disorders
• Open heart surgery within 30 days
• Severe pulmonary hypertension
• Severe asthma
• Sleep apnea requiring continuous positive airway pressure (CPAP)
• Known diaphragm paresis
• Home vent/CPAP
• Restrictive lung disease (such as patients with scoliosis)
• Higher risk for upper respiratory airway occlusion (such as patients with Down Syndrome)
• Cast, brace or splint, fractures
• Degenerative muscular disorder (such as patients with cerebral palsy)
• Areas of impaired skin integrity
• Gastrostomy tube
• Percutaneous endoscopic gastrostomy
• Tracheostomy
• Chest tube(s)
• PACU procedures required (within 1 hour post arrival): post operative (post op) echocardiogram, post op Xray, post op electrocardiogram

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Standard of Care

Active Comparator group

Treatment:

Other: Standard of Care

Weighted blanket

Experimental group

Treatment:

Device: Weighted blanket