CompletedNot Applicable

Post Anesthesia Care Unit (PACU) Weighted Blanket Study

United States72 participantsStarted 2023-03-08

Plain-language 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.

Who can participate

Age range3 Years – 17 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Average Richmond Agitation Sedation Scale (RASS) compared between the two groups

Timeframe: up to 60 minutes (after arrived to PACU)

Trial details

NCT IDNCT05632640

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-22