CPR Rescuer Fatigue on Chest Compression Effectiveness

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01117896
First received: May 4, 2010
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Rescuer Fatigue During CPR
Other: Chest compression on adult and pedi manikins
Other: Use of stepstool during chest compressions

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Effect of Rescuer Fatigue on Chest Compression Effectiveness

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Compression Quality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Metabolic expenditure [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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.

  • Effect of Step stool use [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Visual Analogue Scale (VAS) Score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Correlation between VAS score and time to ineffective compressions

  • Physiologic measures and CC quality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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;

  • Effect of stepstool use on duration of effective compressions. [ Time Frame: 3 yrs ] [ Designated as safety issue: No ]
  • • Correlation of subjective reviewer rating and quantitative objective chest compression quality. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: May 2007
Study Completion Date: July 2012
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • use of stepstool during chest compressions
  • chest compression adult manikin

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.

  Eligibility

Ages Eligible for Study:   22 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117896

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Phila., Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Fran Nadel, MD Children's Hospital of Philadelphia
  More Information

No publications provided by Children's Hospital of Philadelphia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01117896     History of Changes
Other Study ID Numbers: 2007-5-5367
Study First Received: May 4, 2010
Last Updated: October 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
CPR
Rescuer fatigue
Chest Compression effectiveness

Additional relevant MeSH terms:
Fatigue
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014