Post Anesthesia Care Unit (PACU) Weighted Blanket Study

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

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 Overview

• Status: Recruiting
• Conditions: Cardiac Catheterization; Electrophysiology Procedure; Pediatric Cardiology
• Intervention / Treatment: Other: Standard of Care; Device: Weighted blanket

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cynthia Smith; Phone Number: 734-615-0590; Email: csmithw@umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Cynthia Smith; Phone Number: 734-615-0590; Email: csmithw@umich.edu
      • Principal Investigator: Brian Armstrong, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Other: Standard of Care; Following the participants procedure, standard of care will be given in the recovery area.
Experimental: Weighted blanket	Device: Weighted blanket; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Brian Armstrong, RN, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; recovery; agitation; post anesthesia care unit; weighted blanket; Pediatric Cardiology; Emergence delirium
• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: HUM00215568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No