NCT05632640

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 9, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

March 8, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2025

Completed
Last Updated

June 25, 2025

Status Verified

June 1, 2025

Enrollment Period

2.1 years

First QC Date

November 9, 2022

Last Update Submit

June 18, 2025

Conditions

Cardiac CatheterizationElectrophysiology ProcedurePediatric Cardiology

Keywords

weighted blanketpost anesthesia care unitrecoveryagitationpediatricsPediatric CardiologyEmergence delirium

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Analgesia administered in the recovery area

    up to 6 hours after arriving in the PACU

  • Incidence of vascular complications in the recovery area

    up to 6 hours after arriving in the PACU

  • Safety measures assessed by vital sign parameters for absolute oxygen (O2 saturation)

    up to 6 hours after arriving in the PACU

  • Safety measures assessed by vital sign parameters for respiration rate

    up to 6 hours after arriving in the PACU

  • Safety measures assessed by vital sign parameters for respiratory effort

    up to 6 hours after arriving in the PACU

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR
Other: Standard of Care

Weighted blanket

EXPERIMENTAL
Device: Weighted blanket

Interventions

Standard of CareOTHER

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

Standard of Care
Weighted blanketDEVICE

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.

Weighted blanket

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Psychomotor AgitationEmergence Delirium

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorDeliriumConfusionPostoperative ComplicationsPathologic ProcessesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Brian Armstrong, RN

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Registered nurse and principal investigator

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 30, 2022

Study Start

March 8, 2023

Primary Completion

April 22, 2025

Study Completion

April 22, 2025

Last Updated

June 25, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)