NCT00628693

Brief Summary

The design of this protocol is a prospective observational study to objectively measure the rate, depth and quality of chest compressions and ventilations delivered during cardiac arrest in the Pediatric Intensive Care Unit (PICU) and Emergency Department (ED) settings utilizing the MRx/Q-CPR. The data collected will be analyzed for several purposes - for comparison with current American Heart Association (AHA) Cardiopulmonary Resuscitation (CPR) guidelines and to determine chest wall stiffness for CPR modeling efforts and construction of biofidelic manikins or test dummies for CPR and auto safety.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2006

Longer than P75 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 27, 2016

Status Verified

January 1, 2016

Enrollment Period

9 years

First QC Date

February 26, 2008

Last Update Submit

January 26, 2016

Conditions

Keywords

CPR

Outcome Measures

Primary Outcomes (1)

  • To evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR.

    Ongoing

Secondary Outcomes (1)

  • To determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety.

    Ongoing

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Cardiac arrests occurring in the Pediatric Intensive Care Unit or Emergency Department at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR

You may qualify if:

  • Cardiac arrests occurring in the PICU or ED at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR
  • Patient experiencing the arrest must be greater than or equal to 8 years old and receive chest compressions with the Q-CPR sensor employed
  • \- All clinical staff who participate in resuscitation events in CHOP's ICU or ED

You may not qualify if:

  • Cardiac arrests for patients classified as "do not attempt resuscitation" (DNAR) 1. CPR chest compressions without the Q-CPR device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Vinay Nadkarni, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2008

First Posted

March 5, 2008

Study Start

June 1, 2006

Primary Completion

June 1, 2015

Study Completion

November 1, 2015

Last Updated

January 27, 2016

Record last verified: 2016-01

Locations