Post Anesthesia Care Unit (PACU) Weighted Blanket Study

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard of Care

Weighted blanket

About this trial

This is an interventional treatment trial for Cardiac Catheterization focused on measuring weighted blanket, post anesthesia care unit, recovery, agitation, pediatrics, Pediatric Cardiology, Emergence delirium

Eligibility Criteria

3 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Weighted blanket

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Analgesia administered in the recovery area

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

Incidence of vascular complications in the recovery area

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

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.

Safety measures assessed by vital sign parameters for respiration rate

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

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

Full Information

NCT ID

NCT05632640

First Posted

November 9, 2022

Last Updated

September 28, 2023

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT05632640

Brief Title

Post Anesthesia Care Unit (PACU) Weighted Blanket 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 8, 2023 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Catheterization, Electrophysiology Procedure, Pediatric Cardiology

Keywords

weighted blanket, post anesthesia care unit, recovery, agitation, pediatrics, Pediatric Cardiology, Emergence delirium

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Title

Weighted blanket

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Standard of Care

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Weighted blanket

Intervention Description

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 Outcome Measure Information:

Title

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

Description

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).

Time Frame

up to 60 minutes (after arrived to PACU)

Secondary Outcome Measure Information:

Title

Analgesia administered in the recovery area

Description

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

Time Frame