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 range

3 Years – 17 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Cardiac Catheterization trials