Cardiopulmonary ResuscitationNCT03852225
Correlation Between End-tidal CO2 and Degree of Compression of Heart During CPR Measured by Ultrasound
An observational study of Cardiopulmonary Resuscitation and Echocardiography, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
Trial summary
Individual optimization of cardiopulmonary resuscitation (CPR) in real time may increase the success rate of the procedure. End-tidal CO2 (EtCO2) levels reflect cardiac output induced by CPR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Resuscitation, Echocardiography
- What is being tested?
- Intra-arrest echocardiography
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2018to 31 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients meeting inclusion and exclusion criteria
Who may be able to join
- Adult patient resuscitated for out-of-hospital cardiac arrest of non-traumatic origin.
Who cannot join
- Technical unavailability of intra-arrest ultrasonography and capnography.
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Emergency Medical Service of the Central Bohemian Region
Kladno, Central Bohemia
Roman Skulec, MD, 00420 777 577 497, skulec@email.cz
Jitka Callerova, MD, 00420 777 844 471, callerova.hypotermie@email.cz
About this study
Official title: Correlation Between End-tidal CO2 and Degree of Compression of Heart Cavities Measured by Transthoracic Ultrasound During Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
Individual optimization of cardiopulmonary resuscitation (CPR) in real time may increase the success rate of the procedure. End-tidal CO2 (EtCO2) levels reflect cardiac output induced by CPR. Other potential marker of haemodynamic efficacy of CPR is direct measurement of the extent of induced compression of left ventricle (LV), right ventricle (RV) and inferior caval vein (IVC) by ultrasound. We plane to evaluate whether these ultrasound parameters correlate with EtCO2 levels during CPR for out-of-hospital cardiac arrest (OHCA) of non-traumatic origin.
Read the detailed description
Pre-hospital observational study will be realized in the setting of physician-based Emergency Medical System in the Czech republic. 20 patients resuscitated for OHCA of nontraumatic origin are planned to be included to the study. Transthoracic echocardiography will be performed from subcostal view during ongoing chest compressions in all of them and in the time of this investigation EtCO2 level will be recorded. This will be repeated three times during CPR in each patient if possible. Later on, maximal and minimal diameter of LV, RV and IVC will be obtained from the recorded loops and compression index (%) of LV (LVCI), RV (RVCI) and IVC (IVCCI) will be calculated as (maximal-minimal/maximal cavital diameter)x100. Correlations between EtCO2 and LVCI, RVCI and IVCI and CImax will be expressed as Spearman's correlation coefficient.
The results of the study will answer the question whether echocardiographic evaluation of compression of heart cavities during CPR reflect haemodynamic efficacy of CPR. If so, this study will be followed by an interventional clinical trial evaluating the effect of compression depth changes as a response to measured compression of the heart.
- Conditions
- Cardiopulmonary Resuscitation, Echocardiography
- Being tested
- Intra-arrest echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-arrest echocardiographyDiagnostic test
Intra-arrest echocardiography performed by portable ultrasound device during ongoing chest compressions.
| Study group | Role | What they receive |
|---|---|---|
| OHCA patients | Patients resuscitated for out-of-hospital cardiac arrest of non-traumatic origin and investigated by intra-arrest echocardiography. Receives: Diagnostic Test: Intra-arrest echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of EtCO2 level and compression index of left ventricle, right ventricle and inferior caval vein
Compression index of left ventricle, right ventricle and inferior caval vein measured by intra-arrest echocardiography and EtCO2 measured by side stream approach during cardiopulmonary resuscitation.
Measured: Participant will be repeatedly evaluated during cardiopulmonary resuscitation. Therefore, anticipated time frame the time interval will fluctuate from 5 minutes to 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start1 Jan 2018
- Primary completion15 Mar 2019 (estimated)
- Study completion31 Mar 2019 (estimated)
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 Cardiopulmonary ResuscitationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Responsible party
- Principal investigator, Roman Skulec, Emergency Medical Service of the Central Bohemian Region, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852225
- Sponsor's protocol ID
- 2018-02
- Status last verified
- Feb 2019
- First submitted
- 21 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Skulec R, Vojtisek P, Cerny V. Correlation between end-tidal carbon dioxide and the degree of compression of heart cavities measured by transthoracic echocardiography during cardiopulmonary resuscitation for out-of-hospital cardiac arrest. Crit Care. 2019 Oct 29;23(1):334. doi: 10.1186/s13054-019-2607-2.
PubMed 31665061
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between End-tidal CO2 and Degree of Compression of Heart Cavities Measured by Transthoracic Ultrasound During Cardiopulmonary Resuscitation for Out-of-hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03852225
- Acronym / sponsor ID
- 2018-02
- Conditions
- Cardiopulmonary Resuscitation, Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Emergency Medical Service of the Central Bohemian Region, Czech RepublicUniversity, hospital or other
- Collaborators
- Masaryk Hospital Usti nad Labem
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 15 Mar 2019 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 25 Feb 2019 (actual)
- 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.
Individual optimization of cardiopulmonary resuscitation (CPR) in real time may increase the success rate of the procedure. End-tidal CO2 (EtCO2) levels reflect cardiac output induced by CPR. Other potential marker of haemodynamic efficacy of CPR is direct measurement of the extent of induced compression of left ventricle (LV), right ventricle (RV) and inferior caval vein (IVC) by ultrasound. We plane to evaluate whether these ultrasound parameters correlate with EtCO2 levels during CPR for out-of-hospital cardiac arrest (OHCA) of non-traumatic origin.
Detailed description
Pre-hospital observational study will be realized in the setting of physician-based Emergency Medical System in the Czech republic. 20 patients resuscitated for OHCA of nontraumatic origin are planned to be included to the study. Transthoracic echocardiography will be performed from subcostal view during ongoing chest compressions in all of them and in the time of this investigation EtCO2 level will be recorded. This will be repeated three times during CPR in each patient if possible. Later on, maximal and minimal diameter of LV, RV and IVC will be obtained from the recorded loops and compression index (%) of LV (LVCI), RV (RVCI) and IVC (IVCCI) will be calculated as (maximal-minimal/maximal cavital diameter)x100. Correlations between EtCO2 and LVCI, RVCI and IVCI and CImax will be expressed as Spearman's correlation coefficient.
The results of the study will answer the question whether echocardiographic evaluation of compression of heart cavities during CPR reflect haemodynamic efficacy of CPR. If so, this study will be followed by an interventional clinical trial evaluating the effect of compression depth changes as a response to measured compression of the heart.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OHCA patients | – | Diagnostic Test: Intra-arrest echocardiographyPatients resuscitated for out-of-hospital cardiac arrest of non-traumatic origin and investigated by intra-arrest echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients meeting inclusion and exclusion criteria
Key inclusion criteria (1 listed)
- Adult patient resuscitated for out-of-hospital cardiac arrest of non-traumatic origin.
Key exclusion criteria (1 listed)
- Technical unavailability of intra-arrest ultrasonography and capnography.
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 |
|---|---|---|
| Intra-arrest echocardiographyIntra-arrest echocardiography performed by portable ultrasound device during ongoing chest compressions. | Diagnostic test | OHCA patients |
Primary outcome
Correlation of EtCO2 level and compression index of left ventricle, right ventricle and inferior caval vein
Time frame: Participant will be repeatedly evaluated during cardiopulmonary resuscitation. Therefore, anticipated time frame the time interval will fluctuate from 5 minutes to 120 minutes
Compression index of left ventricle, right ventricle and inferior caval vein measured by intra-arrest echocardiography and EtCO2 measured by side stream approach during cardiopulmonary resuscitation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Derived from this study: PubMed 31665061Skulec R, Vojtisek P, Cerny V. Correlation between end-tidal carbon dioxide and the degree of compression of heart cavities measured by transthoracic echocardiography during cardiopulmonary resuscitation for out-of-hospital cardiac arrest. Crit Care. 2019 Oct 29;23(1):334. doi: 10.1186/s13054-019-2607-2.
- Individual participant dataSharing planned: No
Related trials for Cardiopulmonary Resuscitation
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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
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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.
Emergency Medical Service of the Central Bohemian Region
Kladno, Czechia
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 Cardiopulmonary Resuscitation and Echocardiography, run by Emergency Medical Service of the Central Bohemian Region, Czech Republic at 1 site in Czechia.
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 1 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: status not confirmed, as of the sponsor's last update on 25 Feb 2019. 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 Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of EtCO2 level and compression index of left ventricle, right ventricle and inferior caval vein (time frame: Participant will be repeatedly evaluated during cardiopulmonary resuscitation. Therefore, anticipated time frame the time interval will fluctuate from 5 minutes to 120 minutes). 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 NCT03852225, 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 25 Feb 2019.