Cardiopulmonary ArrestNCT03004157
Infant Chest Compression
A study testing cardiopulmonary resuscitation in people with Cardiopulmonary Arrest, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs in the United States annually. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiopulmonary Arrest
- What is being tested?
- cardiopulmonary resuscitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2016to Aug 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- active paramedics
- voluntary consent
Who cannot join
- pregnancy
- back pain
- wrist pain
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Warsaw, Department of Emergency Medicine
Warsaw, Masovia, 02-005
About this study
Official title: A Randomized Comparison of Three Chest Compression Techniques and Associated Hemodynamic Effect During Infant CPR: a Randomized Manikin Study
Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs in the United States annually. Only 8% of the patients survive to hospital discharge and of these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are below age of two and have poorer chance of survival versus older children
- Conditions
- Cardiopulmonary Arrest
- Being tested
- cardiopulmonary resuscitation
- Keywords
- infant, cardiopulmonary resuscitation, hemodynamics, chest compressions
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary resuscitationProcedure or surgery
CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines
| Study group | Role | What they receive |
|---|---|---|
| Two finger technique | Experimental | Two finger technique TFT: the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant CPR by international CPR guidelines Receives: Procedure: cardiopulmonary resuscitation |
| Two thumb technique | Experimental | Two thumb technique TTHT: the two thumbs of the rescuer are placed over the lower third of the sternum, with the fingers encircling the torso and supporting the back. This technique is recommended for two rescuers during infant CPR by international CPR guidelines Receives: Procedure: cardiopulmonary resuscitation |
| new two-thumb technique | Experimental | new two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90 degrees to the chest while closing the fingers of both hands in a fist Receives: Procedure: cardiopulmonary resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP)
Measured: 1 day
Secondary outcomes (2)
diastolic blood pressure
The blood measurement system was calibrated before each CPR setting and blood pressure including diastolic blood pressure (DBP)
Measured: 1 day
mean arterial pressure
The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startJul 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary ArrestStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Jacek Smereka, Antonio Rodríguez-Núñez, Jerzy R Ladny, Steve Leung, Kurt Ruetzler
- Responsible party
- Principal investigator, Łukasz Szarpak, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004157
- Sponsor's protocol ID
- Infant11/2016
- Status last verified
- Dec 2016
- First submitted
- 21 Dec 2016
- Last updated
- 28 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Three Chest Compression Techniques and Associated Hemodynamic Effect During Infant CPR: a Randomized Manikin Study
- ClinicalTrials.gov ID
- NCT03004157
- Acronym / sponsor ID
- Infant11/2016
- Conditions
- Cardiopulmonary Arrest
- Keywords
- infant, cardiopulmonary resuscitation, hemodynamics, chest compressions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Jacek Smereka, Antonio Rodríguez-Núñez, Jerzy R Ladny, Steve Leung, Kurt Ruetzler
- Study start
- Jul 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 28 Dec 2016 (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.
Pediatric cardiac arrest is an uncommon but critical life-threatening event requiring effective cardiopulmonary resuscitation (CPR). About 16,000 pediatric cardiac arrests occurs in the United States annually. Only 8% of the patients survive to hospital discharge and of these, up to two-thirds have neurological sequelae. Majority of pediatric cardiac arrest are below age of two and have poorer chance of survival versus older children
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Two finger technique | Experimental | Procedure: cardiopulmonary resuscitationTwo finger technique TFT: the pediatric thorax is compressed with the tips of two fingers and is recommended for lone rescuer during infant CPR by international CPR guidelines |
| Two thumb technique | Experimental | Procedure: cardiopulmonary resuscitationTwo thumb technique TTHT: the two thumbs of the rescuer are placed over the lower third of the sternum, with the fingers encircling the torso and supporting the back. This technique is recommended for two rescuers during infant CPR by international CPR guidelines |
| new two-thumb technique | Experimental | Procedure: cardiopulmonary resuscitationnew two-thumb technique' (nTTT): this technique consists in using two thumbs directed at the angle of 90 degrees to the chest while closing the fingers of both hands in a fist |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- active paramedics
- voluntary consent
Key exclusion criteria (3 listed)
- pregnancy
- back pain
- wrist pain
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 |
|---|---|---|
| cardiopulmonary resuscitationCPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines | Procedure or surgery | Two finger technique, Two thumb technique, new two-thumb technique |
Primary outcome
systolic blood pressure
Time frame: 1 day
The blood measurement system was calibrated before each CPR setting and blood pressure including systolic blood pressure (SBP)
2 secondary outcomes
diastolic blood pressure
Time frame: 1 day
mean arterial pressure
Time frame: 1 day
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 28 Dec 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cardiopulmonary resuscitation in people with Cardiopulmonary Arrest, run by Medical University of Warsaw at 1 site in Poland.
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 28 Dec 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 Poland. 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?
systolic blood pressure (time frame: 1 day). 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 28 Dec 2016.