Post Anesthesia Care Unit (PACU) Weighted Blanket Study

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Weighted Blankets to Decrease Emergence Agitation, Sedation, and Vascular Complications in a Pediatric Cardiac Post Anesthesia Care Unit Following Cardiac Catheterization

Conditions
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Cardiac Catheterization, Electrophysiology Procedure, Pediatric Cardiology

Intervention / Treatment
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* Other: Standard of Care
* Device: Weighted blanket


Participation Criteria
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Eligibility Criteria
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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
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Minimum Age: 3 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br> | Other: Standard of Care<br>* Following the participants procedure, standard of care will be given in the recovery area.<br>|
| Experimental: Weighted blanket<br> | Device: Weighted blanket<br>* Following the participants procedure once in the recovery area, the nursing staff will place a weighted blanket on the participants. Different weighted blanket sizes will be used based on participants weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Richmond Agitation Sedation Scale (RASS) compared between the two groups | Richmond Agitation Sedation Score is a validated and standardized scoring system ranging from negative 5 (unarousable sedation) to 0 (awake and calm) to 4 (combative). | up to 60 minutes (after arrived to PACU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesia administered in the recovery area | Number of medications (Midazolam, Ketamine, Propofol, Dexmedetomidine, Lorazepam, etc.) required during the recovery period following the procedure. | up to 6 hours after arriving in the PACU | 
| Incidence of vascular complications in the recovery area | This will include participants that have episodes of re-bleeding and hematomas. | up to 6 hours after arriving in the PACU | 
| Safety measures assessed by vital sign parameters for absolute oxygen (O2 saturation) | Absolute oxygen (O2) saturation drop of 10 points or more from recovery area arrival baseline. | up to 6 hours after arriving in the PACU | 
| Safety measures assessed by vital sign parameters for respiration rate | Respiration rate decreased 20% or more from recovery arrival baseline. | up to 6 hours after arriving in the PACU | 
| Safety measures assessed by vital sign parameters for respiratory effort | Increased Respiratory Effort (retractions, labored, nasal flaring, etc.) as compared to recover area arrival baseline | up to 6 hours after arriving in the PACU | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weighted blanket, post anesthesia care unit, recovery, agitation, pediatrics, Pediatric Cardiology, Emergence delirium