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PUCK: Q-CPR Compression Sensor Size Qualification in Children

Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Completed
CT.gov ID
NCT00630773
Collaborator
Laerdal Medical (Industry)
150
Enrollment
1
Location
19.1
Duration (Months)
7.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This prospective, pilot observational study will be performed in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care area (RIPCA) settings at the Children's Hospital of Philadelphia. The differences in trained pediatric health care provider placement of the compression sensor and their assessment of the suitability / willingness to use the current or size modified sensor will be assessed.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Context: Expert recommendations for CPR skills (blowing air into the lungs, pressing on the chest) are poorly followed by health care providers. CPR sensors as small as a hockey "puck" placed on the chest during CPR delivery are able to coach a rescuer to perform better CPR through corrective voice feedback. More adults survive when the quality of CPR (Q-CPR) is improved. This new technology is currently not approved for use in children, specifically 6 months to < 8 years of age.

    Objectives:

    1. Characterize trained pediatric health care provider opinion concerning how appropriate the current Q-CPR sensor ("puck"), FDA approved for children ≥ 8 years of age, is for use in younger children ages 6m to < 8 years of age.

    2. Determine the need for Q-CPR sensor ("puck") size changes to improve its suitability for younger children < 8 years of age, based upon trained pediatric health care provider opinion.

    3. Characterize the amount of Q-CPR sensor ("puck") overlap with standard large and small mock defibrillator electrode pads placed in usual locations on the chest.

    4. Evaluate trained pediatric health care provider self-reported willingness to use current or modified Q-CPR sensors ("pucks") in younger children, 6 months to < 8 years of age.

    Study Design/Setting/Participants: This observational study will be performed in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care area (RIPCA) settings at the Children's Hospital of Philadelphia. Parents and guardians of children ages 6m to < 8 years of age receiving routine clinical care in these patient care areas will be approached for inclusion. Health care practitioners (HCPs) in the ED, OR and PICU will also be approached for inclusion.

    Study Measures: Children will have their age, length, weight, and simple measurements of their chest, neck and abdomen taken. The differences in trained pediatric health care provider placement of the compression sensor and their assessment of the suitability / willingness to use the current or size modified sensor will be assessed.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Feasibility of CPR Adjuncts in Children: Q-CPR Compression Sensor Size Qualification
    Study Start Date :
    Mar 1, 2007
    Actual Primary Completion Date :
    Oct 1, 2008
    Actual Study Completion Date :
    Oct 1, 2008

    Outcome Measures

    Primary Outcome Measures

    1. Determination of how appropriate the existing compression sensor is on children aged 6m to 8yrs, based upon trained pediatric health care provider opinion. [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Months to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Inclusion Criteria - child subjects

    1. Children aged 6 months to 8 years receiving care in the ED, OR, PICU, or RIPCA

    2. Parental or guardian permission (verbal consent), and if appropriate, child assent.

    • Inclusion Criteria - HCPs

    1. Physician, nurse, therapist, or technician involved in patient care in the hospital area (ED, OR, PICU, RIPCA) where a consented child subject is located

    2. Verbal consent obtained

    Exclusion Criteria:
    • child subjects

    1. Obvious chest deformity (pectus excavatum, pectus carinatum) that would make chest dimension measurements difficult or inaccurate.

    2. Absence of child assent as evidenced by either vocal or physical objection to performing measurements.

    • HCPs 1. Previous enrollment in the study for a child subject in the same age strata as the subject enrolled at that time

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital of Philadelphia Phila Pennsylvania United States 19104

    Sponsors and Collaborators

    • Children's Hospital of Philadelphia
    • Laerdal Medical

    Investigators

    • Principal Investigator: Aaron Donoghue, MD, Children's Hospital of Philadelphia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00630773
    Other Study ID Numbers:
    • 2006-12-5077
    First Posted:
    Mar 7, 2008
    Last Update Posted:
    Dec 3, 2008
    Last Verified:
    Dec 1, 2008
    Keywords provided by , ,
    CPR
    compression sensor
    chest compression adjuncts

    Study Results

    No Results Posted as of Dec 3, 2008