Rescuer Fatigue During CPRNCT01117896
CPR Rescuer Fatigue on Chest Compression Effectiveness
A study testing Chest compression on adult and pedi manikins and Use of stepstool during chest compressions in people with Rescuer Fatigue During CPR, run by Children's Hospital of Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 to 65 years
- Conditions the study is for
- Rescuer Fatigue During CPR
- What is being tested?
- Chest compression on adult and pedi manikins and Use of stepstool during chest compressions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Lay practitioners
- Pregnant women
- Chronic medical Condition limiting exertional capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Conditions
- Rescuer Fatigue During CPR
- Being tested
- Chest compression on adult and pedi manikins, Use of stepstool during chest compressions
- Keywords
- CPR, Rescuer fatigue, Chest Compression effectiveness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest compression on adult and pedi manikinsOther
Also called chest compression on adult manikins, chest compression on 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 compressionsOther
Also called chest compression adult manikin
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Use of stepstool during chest compressions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 3 years
Secondary outcomes (4)
Visual Analogue Scale (VAS) Score
Correlation between VAS score and time to ineffective compressions
Measured: 3 years
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;
Measured: 3 years
Effect of stepstool use on duration of effective compressions.
Measured: 3 yrs
• Correlation of subjective reviewer rating and quantitative objective chest compression quality.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2010 (estimated)
- Study startMay 2007
- Primary completionAug 2008
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rescuer Fatigue During CPRStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fran Nadel, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117896
- Sponsor's protocol ID
- 2007-5-5367
- Status last verified
- Oct 2012
- First submitted
- 4 May 2010
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23439892
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rescuer Fatigue on Chest Compression Effectiveness
- ClinicalTrials.gov ID
- NCT01117896
- Acronym / sponsor ID
- 2007-5-5367
- Conditions
- Rescuer Fatigue During CPR
- Keywords
- CPR, Rescuer fatigue, Chest Compression effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 6 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult vs Pedi manikin CC quality | Experimental | Other: Chest compression on adult and pedi manikinsThe 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. |
| Stepstool use | Experimental | Other: Use of stepstool during chest compressionsA 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. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Lay practitioners
- Pregnant women
- Chronic medical Condition limiting exertional capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest compression on adult and pedi manikinsAlso: chest compression on adult manikins, chest compression on pedi manikinsEach 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 | Adult vs Pedi manikin CC quality |
| Use of stepstool during chest compressionsAlso: chest compression adult manikinIn 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 | Stepstool use |
Primary outcome
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.
4 secondary outcomes
Visual Analogue Scale (VAS) Score
Time frame: 3 years
Physiologic measures and CC quality
Time frame: 3 years
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
- Derived from this study: PubMed 23439892Badaki-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.
Related trials for Rescuer Fatigue During CPR
Recruiting
Effect of Bed Height on Chest Compression Quality and Provider Biomechanics During Pediatric CPR Simulation
Pediatric Cardiac Arrest (Simulated), Cardiopulmonary Resuscitation, Simulation Training
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fran Nadel, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest compression on adult and pedi manikins and Use of stepstool during chest compressions in people with Rescuer Fatigue During CPR, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compression Quality (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01117896, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012.