Clinical trial NCT05632640: Post Anesthesia Care Unit (PACU) Weighted Blanket Study
Official title: Effectiveness of Weighted Blankets to Decrease Emergence Agitation, Sedation, and Vascular Complications in a Pediatric Cardiac Post Anesthesia Care Unit Following Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiac Catheterization
Electrophysiology Procedure
Pediatric Cardiology
Keywords: weighted blanket
post anesthesia care unit
recovery
agitation
pediatrics
Pediatric Cardiology
Emergence delirium
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Average Richmond Agitation Sedation Scale (RASS) compared between the two groups
timeFrame: up to 60 minutes (after arrived to PACU)
Secondary outcomes:
measure: Analgesia administered in the recovery area
timeFrame: up to 6 hours after arriving in the PACU
measure: Incidence of vascular complications in the recovery area
timeFrame: up to 6 hours after arriving in the PACU
measure: Safety measures assessed by vital sign parameters for absolute oxygen (O2 saturation)
timeFrame: up to 6 hours after arriving in the PACU
measure: Safety measures assessed by vital sign parameters for respiration rate
timeFrame: up to 6 hours after arriving in the PACU
measure: Safety measures assessed by vital sign parameters for respiratory effort
timeFrame: up to 6 hours after arriving in the PACU
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Brian Armstrong, RN
role: PRINCIPAL_INVESTIGATOR
References: