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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date September 2023
Source University of Michigan
Contact Cynthia Smith
Phone 734-615-0590
Email csmithw@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Standard of Care
Following the participants procedure, standard of care will be given in the recovery area.
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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

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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