Post Anesthesia Care Unit (PACU) Weighted Blanket Study

Last updated: September 4, 2024
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pediatric Health

Treatment

Weighted blanket

Standard of Care

Clinical Study ID

NCT05632640
HUM00215568
  • Ages 3-17
  • All Genders

Study 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

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

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 DownSyndrome)

  • 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

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Weighted blanket
Phase:
Study Start date:
March 08, 2023
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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