RECRUITING
I'm interested ...!!
Post Anesthesia Care Unit (PACU) Weighted Blanket Study
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.
Conditions:
🦠 Cardiac Catheterization 🦠 Electrophysiology Procedure 🦠 Pediatric Cardiology
🗓️ Study Start (Actual) 8 March 2023
🗓️ Primary Completion (Estimated) March 2025
✅ Study Completion (Estimated) March 2025
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Ann Arbor, Michigan, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 3 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 November 2022
  • First Submitted that Met QC Criteria 21 November 2022
  • First Posted 30 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 September 2023
  • Last Update Posted 29 September 2023
  • Last Verified September 2023
I'm interested ...!!