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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator |
| |
| Weighted blanket | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | Following the participants procedure, standard of care will be given in the recovery area. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Analgesia administered in the recovery area | Number of medications (Midazolam, Ketamine, Propofol, Dexmedetomidine, Lorazepam, etc.) required during the recovery period following the procedure. | up to 6 hours after arriving in the PACU |
| Incidence of vascular complications in the recovery area |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Armstrong, RN | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 29, 2026 | May 21, 2026 | 9 | ||
| Jun 3, 2026 |
| ID | Term |
|---|---|
| D011595 | Psychomotor Agitation |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| 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. |
|
This will include participants that have episodes of re-bleeding and hematomas. |
| 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. | 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. | 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 | up to 6 hours after arriving in the PACU |
| Jun 26, 2026 |
| 10 |
| D019954 |
| Neurobehavioral Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003693 | Delirium |
| D003221 | Confusion |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |