Clinical Trials Directory

Trials / Completed

CompletedNCT00630773

Q-CPR Compression Sensor Size Qualification in Children

Feasibility of CPR Adjuncts in Children: Q-CPR Compression Sensor Size Qualification

Status
Completed
Phase
Study type
Observational
Enrollment
150 (actual)
Sponsor
Children's Hospital of Philadelphia · Academic / Other
Sex
All
Age
6 Months – 8 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Timeline

Start date
2007-03-01
Primary completion
2008-10-01
Completion
2008-10-01
First posted
2008-03-07
Last updated
2008-12-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00630773. Inclusion in this directory is not an endorsement.