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Q-CPR Compression Sensor Size Qualification in Children (PUCK)

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ClinicalTrials.gov Identifier: NCT00630773
Recruitment Status : Completed
First Posted : March 7, 2008
Last Update Posted : December 3, 2008
Sponsor:
Collaborator:
Laerdal Medical
Information provided by:
Children's Hospital of Philadelphia

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
CPR

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 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 : March 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008



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. [ Time Frame: 1 year ]


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Ages Eligible for Study:   6 Months to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630773


Locations
United States, Pennsylvania
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

Responsible Party: Aaron Donoghue, MD, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00630773     History of Changes
Other Study ID Numbers: 2006-12-5077
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: December 3, 2008
Last Verified: December 2008

Keywords provided by Children's Hospital of Philadelphia:
CPR
compression sensor
chest compression adjuncts