Post Anesthesia Care Unit (PACU) Weighted Blanket Study
- Conditions
- Cardiac CatheterizationElectrophysiology ProcedurePediatric Cardiology
- Interventions
- Other: Standard of CareDevice: Weighted blanket
- Registration Number
- NCT05632640
- Lead Sponsor
- University of Michigan
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 120
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care Standard of Care - Weighted blanket Weighted blanket -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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.
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.
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.
Trial Locations
- Locations (1)
University of Michigan
🇺🇸Ann Arbor, Michigan, United States