NCT01117896

Brief Summary

This prospective, randomized experimental trial to determine whether the quality of healthcare provider/rescuer chest compressions (CC) deteriorates at the same rate in pediatric models as compared to adult models. To determine the relationship between physiologic/metabolic markers of work in rescuers and chest compression deterioration, and to determine the effect of stepstool use on the quality of chest compressions and metabolic demand. To determine whether the quality of chest compressions deteriorates at the same rate in participants using a stepstool compared to those not using a stepstool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

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

May 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2010

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

1.3 years

First QC Date

May 4, 2010

Last Update Submit

October 24, 2012

Conditions

Keywords

CPRRescuer fatigueChest Compression effectiveness

Outcome Measures

Primary Outcomes (3)

  • Compression Quality

    The primary endpoint will be the difference in mean number of effective compressions per minute in each manikin at times 1, 2, 5 and 10 minutes.

    2 years

  • Metabolic expenditure

    The endpoint will be the difference between mean time to ineffective compressions (defined as 10 consecutive compressions that fail to meet AHA guidelines for depth and rate) and mean time to anaerobic threshold in each manikin.

    2 years

  • Effect of Step stool use

    The endpoint will be the difference between mean time to ineffective compressions (defined as 10 consecutive compressions that fail to meet AHA guidelines for depth and rate) and mean time to anaerobic threshold in each experimental group.

    3 years

Secondary Outcomes (4)

  • Visual Analogue Scale (VAS) Score

    3 years

  • Physiologic measures and CC quality

    3 years

  • Effect of stepstool use on duration of effective compressions.

    3 yrs

  • • Correlation of subjective reviewer rating and quantitative objective chest compression quality.

    3 years

Study Arms (2)

Adult vs Pedi manikin CC quality

EXPERIMENTAL

The primary objective is to determine whether chest compression deterioration occurs at the same rate in pediatric and adult manikins. The primary endpoint will be the difference in mean number of effective compressions per minute in each manikin at times 1, 2, 5 and 10 minutes. Another objective is to identify the correlation between the anaerobic threshold and the deterioration of compressions in each manikin. The endpoint will be the difference between mean time to ineffective compressions (defined as 10 consecutive compressions that fail to meet AHA guidelines for depth and rate) and mean time to anaerobic threshold in each manikin.

Other: Chest compression on adult and pedi manikins

Stepstool use

EXPERIMENTAL

A third main objective is to determine the effect of the stepstool use on the quality of chest compressions and metabolic demand. The endpoint will be the difference between mean time to ineffective compressions (defined as 10 consecutive compressions that fail to meet AHA guidelines for depth and rate) and mean time to anaerobic threshold in each experimental group.

Other: Use of stepstool during chest compressions

Interventions

Each participant will be required to perform chest compressions on all 2 manikins, one on each of 2 assigned days. Participants will be randomized to one of 2 groups differing only in the order of manikins compressed, i.e. pediatric-adult; adult-pediatric, etc.

Also known as: chest compression on adult manikins, chest compression on pedi manikins
Adult vs Pedi manikin CC quality

In the additional arm of the study, a new cohort of participants will use only the adult manikin on two separate sessions. Participants will be randomized to one of two groups differing only in the use of a stepstool.

Also known as: chest compression adult manikin
Stepstool use

Eligibility Criteria

Age22 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females age 22 to 65 years.
  • Resident physicians, fellows, attendings, nurses and emergency medical technicians (EMTs) who routinely perform chest compressions in the Critical Care units and Emergency Department.

You may not qualify if:

  • Lay practitioners
  • Pregnant women
  • Chronic medical Condition limiting exertional capacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Badaki-Makun O, Nadel F, Donoghue A, McBride M, Niles D, Seacrist T, Maltese M, Zhang X, Paridon S, Nadkarni VM. Chest compression quality over time in pediatric resuscitations. Pediatrics. 2013 Mar;131(3):e797-804. doi: 10.1542/peds.2012-1892. Epub 2013 Feb 25.

Study Officials

  • Fran Nadel, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 6, 2010

Study Start

May 1, 2007

Primary Completion

August 1, 2008

Study Completion

July 1, 2012

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations