Cardiac ArrestQ-CPRNCT00628693
Quantitative Measurement of Cardiopulmonary Resuscitation (CPR) During In Hospital Cardiac Arrest
An observational study of Cardiac Arrest and Cardiopulmonary Resuscitation, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
The design of this protocol is a prospective observational study to objectively measure the rate, depth and quality of chest compressions and ventilations delivered during cardiac arrest in the Pediatric Intensive Care Unit (PICU) and Emergency Department (ED) settings utilizing the MRx/Q-CPR. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Cardiac Arrest, Cardiopulmonary Resuscitation
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Nov 2015
- Phase
- Observational
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cardiac arrests occurring in the Pediatric Intensive Care Unit or Emergency Department at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR
Who may be able to join
- Cardiac Arrest Inclusion Criteria:
- Cardiac arrests occurring in the PICU or ED at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR
- Patient experiencing the arrest must be greater than or equal to 8 years old and receive chest compressions with the Q-CPR sensor employed
- Clinical Staff Inclusion Criteria:
- All clinical staff who participate in resuscitation events in CHOP's ICU or ED
Who cannot join
- Cardiac arrests for patients classified as "do not attempt resuscitation" (DNAR) 1. CPR chest compressions without the Q-CPR device
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: Quantitative Measurement of Cardiopulmonary Resuscitation During In Hospital Cardiac Arrest
The design of this protocol is a prospective observational study to objectively measure the rate, depth and quality of chest compressions and ventilations delivered during cardiac arrest in the Pediatric Intensive Care Unit (PICU) and Emergency Department (ED) settings utilizing the MRx/Q-CPR. The data collected will be analyzed for several purposes - for comparison with current American Heart Association (AHA) Cardiopulmonary Resuscitation (CPR) guidelines and to determine chest wall stiffness for CPR modeling efforts and construction of biofidelic manikins or test dummies for CPR and auto safety.
Read the detailed description
Context: Cardiopulmonary Resuscitation (CPR) guidelines recommend target values for selected CPR parameters related to rate and depth of chest compressions and ventilations, and avoidance of CPR-free intervals. Recent studies on adult patients however show that rescuers often do not adhere to these guidelines. There is currently very little data on the quality of CPR performed on pediatric patients, but given the close similarity in therapy it can be expected that the adherence to Guidelines is suboptimal for this patient group as well. Feedback on quality of chest compressions and ventilations delivered during CPR are most frequently guided by a subjective "code leader", and not objective measurements. Quantitative systems that provide CPR feedback have demonstrated improvement to adult patient treatment. Based on these studies, these feedback systems (termed Quality of CPR or Q-CPR systems) were further improved in a new device called Heartstart MRx with Q-CPR option (MRx/Q-CPR). These devices have been approved by the FDA for use for patients >8 years. The MRX/Q-CPR, attached by a cord to the defibrillator/monitor, detects, displays and records the rate, force and the depth of compressions through an accelerometer and force transducer inside the compression pad. These devices have currently been approved by the CHOP Resuscitation Committee and Medical device committee for clinical implementation in the CHOP Intensive Care units (ICU) and Emergency Department (ED).
Objectives: The goal of this study is to record and analyze the data from the MRx/Q-CPR during in-hospital cardiac arrests of children > 8 years for two research objectives. The primary research objective is to evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR. A secondary research objective is to determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation
- Keywords
- CPR
- Medical subject headings
- Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR.
Measured: Ongoing
Secondary outcomes (1)
To determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startJun 2006
- Primary completionJun 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Vinay Nadkarni, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628693
- Sponsor's protocol ID
- 2006-6-4839
- Other IDs
- 1K23HD062629-01A1
- Acronym
- Q-CPR
- Status last verified
- Jan 2016
- First submitted
- 26 Feb 2008
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Measurement of Cardiopulmonary Resuscitation During In Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT00628693
- Acronym / sponsor ID
- Q-CPR / 2006-6-4839
- Conditions
- Cardiac Arrest, Cardiopulmonary Resuscitation
- Keywords
- CPR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2006
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Mar 2008 (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.
The design of this protocol is a prospective observational study to objectively measure the rate, depth and quality of chest compressions and ventilations delivered during cardiac arrest in the Pediatric Intensive Care Unit (PICU) and Emergency Department (ED) settings utilizing the MRx/Q-CPR. The data collected will be analyzed for several purposes - for comparison with current American Heart Association (AHA) Cardiopulmonary Resuscitation (CPR) guidelines and to determine chest wall stiffness for CPR modeling efforts and construction of biofidelic manikins or test dummies for CPR and auto safety.
Detailed description
Context: Cardiopulmonary Resuscitation (CPR) guidelines recommend target values for selected CPR parameters related to rate and depth of chest compressions and ventilations, and avoidance of CPR-free intervals. Recent studies on adult patients however show that rescuers often do not adhere to these guidelines. There is currently very little data on the quality of CPR performed on pediatric patients, but given the close similarity in therapy it can be expected that the adherence to Guidelines is suboptimal for this patient group as well. Feedback on quality of chest compressions and ventilations delivered during CPR are most frequently guided by a subjective "code leader", and not objective measurements. Quantitative systems that provide CPR feedback have demonstrated improvement to adult patient treatment. Based on these studies, these feedback systems (termed Quality of CPR or Q-CPR systems) were further improved in a new device called Heartstart MRx with Q-CPR option (MRx/Q-CPR). These devices have been approved by the FDA for use for patients >8 years. The MRX/Q-CPR, attached by a cord to the defibrillator/monitor, detects, displays and records the rate, force and the depth of compressions through an accelerometer and force transducer inside the compression pad. These devices have currently been approved by the CHOP Resuscitation Committee and Medical device committee for clinical implementation in the CHOP Intensive Care units (ICU) and Emergency Department (ED).
Objectives: The goal of this study is to record and analyze the data from the MRx/Q-CPR during in-hospital cardiac arrests of children > 8 years for two research objectives. The primary research objective is to evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR. A secondary research objective is to determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiac arrests occurring in the Pediatric Intensive Care Unit or Emergency Department at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR
Key inclusion criteria (5 listed)
- Cardiac arrests occurring in the PICU or ED at The Children's Hospital of Philadelphia equipped with the MRx/Q-CPR
- Patient experiencing the arrest must be greater than or equal to 8 years old and receive chest compressions with the Q-CPR sensor employed
- All clinical staff who participate in resuscitation events in CHOP's ICU or ED
Key exclusion criteria (1 listed)
- Cardiac arrests for patients classified as "do not attempt resuscitation" (DNAR) 1. CPR chest compressions without the Q-CPR device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR.
Time frame: Ongoing
1 secondary outcome
To determine the chest wall stiffness of children in order to improve quantitative CPR modeling efforts and to facilitate the construction of more biofidelic pediatric manikins for CPR simulation and test dummies for automotive safety.
Time frame: Ongoing
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 27 Jan 2016.
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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.
Vinay Nadkarni, 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?
An observational study of Cardiac Arrest and Cardiopulmonary Resuscitation, 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 5 inclusion and 1 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 27 Jan 2016. 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?
To evaluate the rate, depth, and quality of chest compressions and ventilations delivered to children during in-hospital CPR. (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2016.