Post Anesthesia Care Unit (PACU) Weighted Blanket Study

University of Michigan72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cardiac Catheterization Electrophysiology Procedure Pediatric Cardiology

Interventions

Standard of CareOTHER

Following the participants procedure, standard of care will be given in the recovery area.

Weighted blanketDEVICE

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.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Michigan

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

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).

Time frame: up to 60 minutes (after arrived to PACU)

Secondary Outcomes

Analgesia administered in the recovery area

Number of medications (Midazolam, Ketamine, Propofol, Dexmedetomidine, Lorazepam, etc.) required during the recovery period following the procedure.