Post Anesthesia Care Unit (PACU) Weighted Blanket Study

NCT ID: NCT05632640

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-08
• Study Completion Date: 2025-04-22

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.

Conditions

Cardiac Catheterization; Electrophysiology Procedure; Pediatric Cardiology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Following the participants procedure, standard of care will be given in the recovery area.

Weighted blanket

Group Type: EXPERIMENTAL

Weighted blanket

Intervention Type: DEVICE

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.

Interventions

Standard of Care

Following the participants procedure, standard of care will be given in the recovery area.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Brian J Armstrong

Registered nurse and principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Armstrong, RN

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00215568

Identifier Type: -

Identifier Source: org_study_id