CPR Rescuer Fatigue on Chest Compression Effectiveness

Rescuer Fatigue During CPR Clinical Trial

Official title:

Effect of Rescuer Fatigue on Chest Compression Effectiveness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117896
• Other study ID #: 2007-5-5367
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: October 24, 2012
• Start date: May 2007
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: July 2012
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 22 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fatigue
• Rescuer Fatigue During CPR

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Phila.	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Visual Analogue Scale (VAS) Score	Correlation between VAS score and time to ineffective compressions	3 years	No
Secondary	Physiologic measures and CC quality	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	No
Secondary	Effect of stepstool use on duration of effective compressions.		3 yrs	No
Secondary	• Correlation of subjective reviewer rating and quantitative objective chest compression quality.		3 years	No