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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

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

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
Recruiting

Other trials in Czechia

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 groups in NCT03852225
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.

1 Jan 201831 Mar 2019

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)

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

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Compression-Only Versus Standard Basic Life Support Training in Nursing Students
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Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
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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)

All Cardiopulmonary Resuscitation trials

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.

Detailed description

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

Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
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)

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

00420 777 577 497

skulec@email.cz

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.