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NCT Number: NCT05632640

Post Anesthesia Care Unit (PACU) Weighted Blanket Study

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.

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Key information

Conditions

Cardiac Catheterization Aberrant Motor Behavior in Dementia Behavior Behavioral Symptoms Confusion Delirium Dyskinesias Electrophysiology Procedure Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Cardiology Postoperative Complications Psychomotor Agitation Psychomotor Disorders Signs and Symptoms

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of care

Other

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

Weighted blanket

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.

Primary outcomes

  1. Average Richmond Agitation Sedation Scale (RASS) compared between the two groups

    Time frame: up to 60 minutes (after arrived to PACU)

    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).

Secondary outcomes

  1. Analgesia administered in the recovery area

    Time frame: up to 6 hours after arriving in the PACU

    Number of medications (Midazolam, Ketamine, Propofol, Dexmedetomidine, Lorazepam, etc.) required during the recovery period following the procedure.

  2. Incidence of vascular complications in the recovery area

    Time frame: up to 6 hours after arriving in the PACU

    This will include participants that have episodes of re-bleeding and hematomas.

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

    Time frame: up to 6 hours after arriving in the PACU

    Absolute oxygen (O2) saturation drop of 10 points or more from recovery area arrival baseline.

  4. Safety measures assessed by vital sign parameters for respiration rate

    Time frame: up to 6 hours after arriving in the PACU

    Respiration rate decreased 20% or more from recovery arrival baseline.

  5. Safety measures assessed by vital sign parameters for respiratory effort

    Time frame: up to 6 hours after arriving in the PACU

    Increased Respiratory Effort (retractions, labored, nasal flaring, etc.) as compared to recover area arrival baseline

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Effectiveness of Weighted Blankets to Decrease Emergence Agitation, Sedation, and Vascular Complications in a Pediatric Cardiac Post Anesthesia Care Unit Following Cardiac Catheterization

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 30, 2022
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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