Cardiac Catheterization Clinical Trial
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
NCT number | NCT05632640 |
Other study ID # | HUM00215568 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 8, 2023 |
Est. completion date | March 2025 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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