NCT01265316

Brief Summary

Outcomes for pediatric cardiopulmonary resuscitation (CPR) are suboptimal. CPR quality is directly related to resuscitation outcome, yet numerous deficiencies in CPR quality have been documented in adult studies. While similar deficiencies can be expected in pediatric resuscitation attempts, there is little to no data evaluating the existing quality of CPR performed during resuscitation attempts. Therefore, the objective of this study is to quantitatively evaluate existing CPR quality using a Q-CPR compression sensor manufactured by Philips Medical Systems with technology from Laerdal Medical.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2010

Typical duration 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

October 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

December 21, 2010

Last Update Submit

February 5, 2014

Conditions

Keywords

Cardiac arrest, CPR, pediatric

Outcome Measures

Primary Outcomes (1)

  • Determine the existing quality of CPR performed during the resuscitation of children 1year to less than 8 years of age.

    2 years

Secondary Outcomes (1)

  • 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.

    2 years

Interventions

There is no intervention for this study. The pre-NSR IDE for this study is simply a modification to allow for recording of data without intervention.

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Cardiac arrests (chest compression events) occurring in the pediatric intensive care unit having consented for enrollment in the study.

You may qualify if:

  • Cardiac arrests (chest compression events) occurring in the pediatric intensive care unit
  • Arrest patient age 1 year to less than 8 years
  • Subject pre-screened by a member of the Cardiac Arrest Research Team for safe use of the modified MRx/Quality of CPR (Q-CPR)
  • The modified MRx/Quality of CPR (Q-CPR) Compressions Sensor deployed
  • All clinical staff who participate in enrolled resuscitation events and who provided chest compressions

You may not qualify if:

  • Cardiac arrests for patients classified as do not attempt resuscitation (DNAR)
  • Patient condition or size resulting in attending physician or physician fellow designee deciding not to deploy the modified MRx/Quality of CPR (Q-CPR) chest compression sensor (e.g., recent sternotomy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 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, MS

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 21, 2010

First Posted

December 23, 2010

Study Start

October 1, 2010

Primary Completion

January 1, 2013

Study Completion

June 1, 2013

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations