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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03852225
Other study ID # 2018-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date March 31, 2019

Study information

Verified date February 2019
Source Emergency Medical Service of the Central Bohemian Region, Czech Republic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 31, 2019
Est. primary completion date March 15, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patient resuscitated for out-of-hospital cardiac arrest of non-traumatic origin.

Exclusion Criteria:

- Technical unavailability of intra-arrest ultrasonography and capnography.

Study Design


Intervention

Diagnostic Test:
Intra-arrest echocardiography
Intra-arrest echocardiography performed by portable ultrasound device during ongoing chest compressions.

Locations

Country Name City State
Czechia Emergency Medical Service of the Central Bohemian Region Kladno Central Bohemian Region

Sponsors (2)

Lead Sponsor Collaborator
Emergency Medical Service of the Central Bohemian Region, Czech Republic Masaryk Hospital Usti nad Labem

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Participant will be repeatedly evaluated during cardiopulmonary resuscitation. Therefore, anticipated time frame the time interval will fluctuate from 5 minutes to 120 minutes
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