Cardiac CatheterizationNCT05632640
Post Anesthesia Care Unit (PACU) Weighted Blanket Study
A study testing Weighted blanket in people with Cardiac Catheterization and Electrophysiology Procedure, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Cardiac Catheterization, Electrophysiology Procedure, Pediatric Cardiology
- What is being tested?
- Weighted blanket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2023to 22 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Weighted Blankets to Decrease Emergence Agitation, Sedation, and Vascular Complications in a Pediatric Cardiac Post Anesthesia Care Unit Following Cardiac Catheterization
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.
- Being tested
- Standard of Care, Weighted blanket
- Keywords
- weighted blanket, post anesthesia care unit, recovery, agitation, pediatrics, Pediatric Cardiology, Emergence delirium
- Medical subject headings
- Psychomotor Agitation, Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of CareOther
Following the participants procedure, standard of care will be given in the recovery area.
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | Not described Receives: Other: Standard of Care |
| Weighted blanket | Experimental | Not described Receives: Device: Weighted blanket |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 60 minutes (after arrived to PACU)
Secondary outcomes (5)
Analgesia administered in the recovery area
Number of medications (Midazolam, Ketamine, Propofol, Dexmedetomidine, Lorazepam, etc.) required during the recovery period following the procedure.
Measured: up to 6 hours after arriving in the PACU
Incidence of vascular complications in the recovery area
This will include participants that have episodes of re-bleeding and hematomas.
Measured: up to 6 hours after arriving in the PACU
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.
Measured: up to 6 hours after arriving in the PACU
Safety measures assessed by vital sign parameters for respiration rate
Respiration rate decreased 20% or more from recovery arrival baseline.
Measured: up to 6 hours after arriving in the PACU
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
Measured: up to 6 hours after arriving in the PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start8 Mar 2023
- Primary completion22 Apr 2025
- Study completion22 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac CatheterizationStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian J Armstrong, University of Michigan
- Investigators
- Brian Armstrong, RN, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632640
- Sponsor's protocol ID
- HUM00215568
- Status last verified
- Jun 2025
- First submitted
- 9 Nov 2022
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No