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

This study has been completed.
Sponsor:
Collaborator:
Laerdal Medical
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00630773
First received: February 28, 2008
Last updated: December 2, 2008
Last verified: December 2008

February 28, 2008
December 2, 2008
March 2007
October 2008   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00630773 on ClinicalTrials.gov Archive Site
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Q-CPR Compression Sensor Size Qualification in Children
Feasibility of CPR Adjuncts in Children: Q-CPR Compression Sensor Size Qualification

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

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.

CPR
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
6 Months to 8 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00630773
2006-12-5077
No
Aaron Donoghue, MD, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Laerdal Medical
Principal Investigator: Aaron Donoghue, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP