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CPR Rescuer Fatigue on Chest Compression Effectiveness

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ClinicalTrials.gov Identifier: NCT01117896
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : October 26, 2012
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

May 4, 2010
May 6, 2010
October 26, 2012
May 2007
August 2008   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT01117896 on ClinicalTrials.gov Archive Site
  • Visual Analogue Scale (VAS) Score [ Time Frame: 3 years ]
    Correlation between VAS score and time to ineffective compressions
  • 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;
  • Effect of stepstool use on duration of effective compressions. [ Time Frame: 3 yrs ]
  • • Correlation of subjective reviewer rating and quantitative objective chest compression quality. [ Time Frame: 3 years ]
  • VAS Score [ Time Frame: 3 years ]
    Correlation between VAS score and time to ineffective compressions
  • Physiologic measures and CC quality [ Time Frame: 3 years ]
    Correlation between physiologic measures (anaerobic threshold, VO2, VCO2, O2P, VE and RER) and time to ineffective compressions;
  • Effect of stepstool use on duration of effective compressions. [ Time Frame: 3 yrs ]
  • • Correlation of subjective reviewer rating and quantitative objective chest compression quality. [ Time Frame: 3 years ]
Not Provided
Not Provided
 
CPR Rescuer Fatigue on Chest Compression Effectiveness
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Rescuer Fatigue During CPR
  • 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
  • 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 Name: chest compression adult manikin
  • 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.

    Intervention: Other: Chest compression on adult and 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.
    Intervention: Other: Use of stepstool during chest compressions
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
90
July 2012
August 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
22 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01117896
2007-5-5367
No
Not Provided
Not Provided
Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Fran Nadel, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP