CPRPUCKNCT00630773
Q-CPR Compression Sensor Size Qualification in Children
An observational study of CPR, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This prospective, pilot observational study will be performed in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care area (RIPCA) settings at the Children's Hospital of Philadelphia. Read more about this study
- Who is it for?
- Ages 6 months to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- CPR
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Oct 2008
- 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 6 months to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and Regular Inpatient Care Area (RIPCA) settings at the Children's Hospital of Philadelphia.
Who may be able to join
- Children aged 6 months to 8 years receiving care in the ED, OR, PICU, or RIPCA
- Parental or guardian permission (verbal consent), and if appropriate, child assent.
- Physician, nurse, therapist, or technician involved in patient care in the hospital area (ED, OR, PICU, RIPCA) where a consented child subject is located
- Verbal consent obtained
Who cannot join
- child subjects
- Obvious chest deformity (pectus excavatum, pectus carinatum) that would make chest dimension measurements difficult or inaccurate.
- Absence of child assent as evidenced by either vocal or physical objection to performing measurements.
- HCPs 1. Previous enrollment in the study for a child subject in the same age strata as the subject enrolled at that time
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: Feasibility of CPR Adjuncts in Children: Q-CPR Compression Sensor Size Qualification
This prospective, pilot observational study will be performed in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care area (RIPCA) settings at the Children's Hospital of Philadelphia. The differences in trained pediatric health care provider placement of the compression sensor and their assessment of the suitability / willingness to use the current or size modified sensor will be assessed.
Read the detailed description
Context: Expert recommendations for CPR skills (blowing air into the lungs, pressing on the chest) are poorly followed by health care providers. CPR sensors as small as a hockey "puck" placed on the chest during CPR delivery are able to coach a rescuer to perform better CPR through corrective voice feedback. More adults survive when the quality of CPR (Q-CPR) is improved. This new technology is currently not approved for use in children, specifically 6 months to < 8 years of age.
Objectives:
- Characterize trained pediatric health care provider opinion concerning how appropriate the current Q-CPR sensor ("puck"), FDA approved for children ≥ 8 years of age, is for use in younger children ages 6m to < 8 years of age.
- Determine the need for Q-CPR sensor ("puck") size changes to improve its suitability for younger children < 8 years of age, based upon trained pediatric health care provider opinion.
- Characterize the amount of Q-CPR sensor ("puck") overlap with standard large and small mock defibrillator electrode pads placed in usual locations on the chest.
- Evaluate trained pediatric health care provider self-reported willingness to use current or modified Q-CPR sensors ("pucks") in younger children, 6 months to < 8 years of age.
Study Design/Setting/Participants: This observational study will be performed in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care area (RIPCA) settings at the Children's Hospital of Philadelphia. Parents and guardians of children ages 6m to < 8 years of age receiving routine clinical care in these patient care areas will be approached for inclusion. Health care practitioners (HCPs) in the ED, OR and PICU will also be approached for inclusion.
Study Measures: Children will have their age, length, weight, and simple measurements of their chest, neck and abdomen taken. The differences in trained pediatric health care provider placement of the compression sensor and their assessment of the suitability / willingness to use the current or size modified sensor will be assessed.
- Conditions
- CPR
- Keywords
- CPR, compression sensor, chest compression adjuncts
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of how appropriate the existing compression sensor is on children aged 6m to 8yrs, based upon trained pediatric health care provider opinion.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMar 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Laerdal Medical
- Investigators
- Aaron Donoghue, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630773
- Sponsor's protocol ID
- 2006-12-5077
- Acronym
- PUCK
- Status last verified
- Dec 2008
- First submitted
- 28 Feb 2008
- Last updated
- 3 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of CPR Adjuncts in Children: Q-CPR Compression Sensor Size Qualification
- ClinicalTrials.gov ID
- NCT00630773
- Acronym / sponsor ID
- PUCK / 2006-12-5077
- Conditions
- CPR
- Keywords
- CPR, compression sensor, chest compression adjuncts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Laerdal Medical
- Study start
- Mar 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 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.
This prospective, pilot observational study will be performed in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care area (RIPCA) settings at the Children's Hospital of Philadelphia. The differences in trained pediatric health care provider placement of the compression sensor and their assessment of the suitability / willingness to use the current or size modified sensor will be assessed.
Detailed description
Context: Expert recommendations for CPR skills (blowing air into the lungs, pressing on the chest) are poorly followed by health care providers. CPR sensors as small as a hockey "puck" placed on the chest during CPR delivery are able to coach a rescuer to perform better CPR through corrective voice feedback. More adults survive when the quality of CPR (Q-CPR) is improved. This new technology is currently not approved for use in children, specifically 6 months to < 8 years of age.
Objectives:
- Characterize trained pediatric health care provider opinion concerning how appropriate the current Q-CPR sensor ("puck"), FDA approved for children ≥ 8 years of age, is for use in younger children ages 6m to < 8 years of age.
- Determine the need for Q-CPR sensor ("puck") size changes to improve its suitability for younger children < 8 years of age, based upon trained pediatric health care provider opinion.
- Characterize the amount of Q-CPR sensor ("puck") overlap with standard large and small mock defibrillator electrode pads placed in usual locations on the chest.
- Evaluate trained pediatric health care provider self-reported willingness to use current or modified Q-CPR sensors ("pucks") in younger children, 6 months to < 8 years of age.
Study Design/Setting/Participants: This observational study will be performed in the Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and regular inpatient care area (RIPCA) settings at the Children's Hospital of Philadelphia. Parents and guardians of children ages 6m to < 8 years of age receiving routine clinical care in these patient care areas will be approached for inclusion. Health care practitioners (HCPs) in the ED, OR and PICU will also be approached for inclusion.
Study Measures: Children will have their age, length, weight, and simple measurements of their chest, neck and abdomen taken. The differences in trained pediatric health care provider placement of the compression sensor and their assessment of the suitability / willingness to use the current or size modified sensor will be assessed.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Emergency Department (ED), Pediatric Intensive Care Unit (PICU), Operating Room (OR) and Regular Inpatient Care Area (RIPCA) settings at the Children's Hospital of Philadelphia.
Key inclusion criteria (4 listed)
Key exclusion criteria (4 listed)
- child subjects
- HCPs 1. Previous enrollment in the study for a child subject in the same age strata as the subject enrolled at that time
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
Determination of how appropriate the existing compression sensor is on children aged 6m to 8yrs, based upon trained pediatric health care provider opinion.
Time frame: 1 year
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 3 Dec 2008.
Related trials for CPR
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruiting
The OXY-VENT Study
Cardiac Arrest (CA), Cardiopulmonary Resuscitation (CPR)
Not yet recruiting
Generative AI and Gamified Simulation-Based Train-the-Trainer Basic Life Support Training for High School Teachers in Vietnam
Cardiac Arrest, Cardiopulmonary Resuscitation
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
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.
Aaron Donoghue, 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 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 4 inclusion and 4 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 3 Dec 2008. 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?
Determination of how appropriate the existing compression sensor is on children aged 6m to 8yrs, based upon trained pediatric health care provider opinion. (time frame: 1 year). 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 3 Dec 2008.