CPR Rescuer Fatigue on Chest Compression Effectiveness

October 24, 2012 updated by: Children's Hospital of Philadelphia

Effect of Rescuer Fatigue on Chest Compression Effectiveness

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Context:

Pediatric cardiac arrests result in poor outcomes. Effective chest compressions improve survival in such patients. Unfortunately, compressions are generally inadequately performed and the quality of compressions given deteriorates rapidly with time. Current American Heart Association (AHA) guidelines call for faster and deeper chest compressions with minimization of interruptions. The effect of fatigue on operational performance while adhering strictly to these AHA guidelines is unknown. In addition, there is little pediatric data on rescuer fatigue and chest compression deterioration. Also, the use of a stepstool may affect the quality of chest compressions and may also have an impact on the fatigue of the rescuer. Understanding the biomechanics during optimal chest compression performance may prove useful in the recommendations of conditions and equipment for execution of more effective chest compressions during a cardiac arrest. We will aim to observe and understand the biomechanical qualities that allow for the most effective compressions.

Objectives:

  1. To determine whether the quality of chest compressions 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.
  2. 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.

Study Design/Setting/Participants:

This prospective, randomized experimental trial will be performed at the Children's Hospital of Philadelphia. Participants will be healthcare practitioners who routinely provide chest compressions in the course of their work. Lay practitioners will be excluded.

Study Measures:

Participants will be asked to perform continuous chest compressions on pediatric and adult sized manikins. Compression rate, depth, applied force as well as participant physiologic work efficiency and anaerobic threshold will be recorded. To evaluate the second objective, a new cohort of participants will perform continuous chest compressions on an adult sized manikin with and without a stepstool.. Compression rate, depth, applied force as well as participant physiologic work efficiency and anaerobic threshold will also be recorded. Videotaping of each subject will also be used for comparison of subjective assessment of chest compression quality and objective chest compression quality data.

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Phila., Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Lay practitioners
  2. Pregnant women
  3. Chronic medical Condition limiting exertional capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Adult vs Pedi manikin CC quality

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
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.
Other Names:
  • chest compression on adult manikins
  • chest compression on pedi manikins
EXPERIMENTAL: Stepstool use
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
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.
Other Names:
  • chest compression adult manikin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compression Quality
Time Frame: 2 years
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
Time Frame: 2 years
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
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS) Score
Time Frame: 3 years
Correlation between VAS score and time to ineffective compressions
3 years
Physiologic measures and CC quality
Time Frame: 3 years
Correlation between physiologic measures [anaerobic threshold, Minute oxygen consumption (VO2), Minute carbon dioxide production (VCO2), Oxygen pulse (O2P), Maximal minute ventilation (VE) and Respiratory Exchange Ratio (RER)] and time to ineffective compressions;
3 years
Effect of stepstool use on duration of effective compressions.
Time Frame: 3 yrs
3 yrs
• Correlation of subjective reviewer rating and quantitative objective chest compression quality.
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Fran Nadel, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (ESTIMATE)

May 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 24, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-5-5367

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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