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Post Anesthesia Care Unit (PACU) Weighted Blanket Study

NCT05632640 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-06-25

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Brian Armstrong, RN · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-08
Primary Completion
2025-04-22
Completion
2025-04-22
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05632640 on ClinicalTrials.gov