Cardiac Catheterization, Electrophysiology Procedure, Pediatric Cardiology
Conditions
Keywords
weighted blanket, post anesthesia care unit, recovery, agitation, pediatrics, Pediatric Cardiology, Emergence delirium
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.
Interventions
OTHERStandard of Care
Following the participants procedure, standard of care will be given in the recovery area.
DEVICEWeighted 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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Richmond Agitation Sedation Scale (RASS) compared between the two groups | up to 60 minutes (after arrived to PACU) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesia administered in the recovery area | up to 6 hours after arriving in the PACU | Number of medications (Midazolam, Ketamine, Propofol, Dexmedetomidine, Lorazepam, etc.) required during the recovery period following the procedure. |
| Incidence of vascular complications in the recovery area | up to 6 hours after arriving in the PACU | This will include participants that have episodes of re-bleeding and hematomas. |
| Safety measures assessed by vital sign parameters for absolute oxygen (O2 saturation) | up to 6 hours after arriving in the PACU | Absolute oxygen (O2) saturation drop of 10 points or more from recovery area arrival baseline. |
| Safety measures assessed by vital sign parameters for respiration rate | up to 6 hours after arriving in the PACU | Respiration rate decreased 20% or more from recovery arrival baseline. |
| Safety measures assessed by vital sign parameters for respiratory effort | up to 6 hours after arriving in the PACU | Increased Respiratory Effort (retractions, labored, nasal flaring, etc.) as compared to recover area arrival baseline |
Countries
United States
Outcome results
None listed