NCT00630773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

December 3, 2008

Status Verified

December 1, 2008

Enrollment Period

1.6 years

First QC Date

February 28, 2008

Last Update Submit

December 2, 2008

Conditions

CPR

Keywords

CPRcompression sensorchest compression adjuncts

Outcome Measures

Primary Outcomes (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

Age6 Months - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Children aged 6 months to 8 years receiving care in the ED, OR, PICU, or RIPCA
  • Parental or guardian permission (verbal consent), and if appropriate, child assent.
  • Physician, nurse, therapist, or technician involved in patient care in the hospital area (ED, OR, PICU, RIPCA) where a consented child subject is located
  • Verbal consent obtained

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Officials

  • Aaron Donoghue, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2008

First Posted

March 7, 2008

Study Start

March 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 3, 2008

Record last verified: 2008-12

Locations

US(1)