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Search / Trial NCT05632640

Post Anesthesia Care Unit (PACU) Weighted Blanket Study

Launched by UNIVERSITY OF MICHIGAN · Nov 21, 2022

Trial Information

Current as of June 26, 2025

Completed

Keywords

Weighted Blanket Post Anesthesia Care Unit Recovery Agitation Pediatrics Pediatric Cardiology Emergence Delirium

ClinConnect Summary

The Post Anesthesia Care Unit (PACU) Weighted Blanket Study is a clinical trial that is exploring whether using weighted blankets can help calm patients after they have undergone cardiac catheterization or electrophysiology procedures. The goal is to see if these blankets can reduce feelings of agitation, which may lead to less need for extra sedation (medication to make you sleepy) and possibly lower the chances of complications related to the procedure.

To participate in this study, patients need to be between 2 and 17 years old and scheduled for certain heart procedures, with a plan for recovery in the cardiac PACU for at least 2 hours. However, some patients may not be eligible, including those who weigh less than 40 pounds or more than 220 pounds, or those with certain medical conditions like severe asthma or sleep apnea. Participants can expect to receive care with the added comfort of a weighted blanket during their recovery, and the study is currently looking for volunteers to join.

Gender

ALL

Eligibility criteria

  • 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

About University Of Michigan

The University of Michigan, a leading academic institution renowned for its commitment to advancing healthcare and medical research, serves as a prominent clinical trial sponsor. With a robust infrastructure that supports innovative research initiatives, the university leverages its multidisciplinary expertise to conduct a wide array of clinical trials aimed at improving patient outcomes and advancing medical knowledge. Through its state-of-the-art facilities and collaborative environment, the University of Michigan fosters partnerships between researchers, clinicians, and industry leaders, ensuring the development of cutting-edge therapies and interventions that address pressing health challenges.

Locations

Ann Arbor, Michigan, United States

Patients applied

0 patients applied

Trial Officials

Brian Armstrong, RN

Principal Investigator

University of Michigan

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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