Protocol summary

Study aim
The aim of this study was to use cardiac sonography as a diagnostic method for the treatment of patients with cardiac arrest and asystole and PEA rhythm by emergency physicians and, if possible, taking therapeutic measures based on specific etiology.
Design
Randomized, parallel group clinical trial
Settings and conduct
In the present study, all adult patients who entered the emergency department of Alzahra and Kashani hospitals with cardiac arrest are divided into two groups using a randomized blocking method. In the first group, the patient undergoes ultrasound during the resuscitation and in the second group, the standard resuscitation is performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with cardiopulmonary arrest without organized rhythm. Exclusion criteria: Failure to perform ultrasound resuscitation.
Intervention groups
During resuscitation, without interference in resuscitation measures, an ultrasound probe placed in the subxiphoid area by an emergency medicine specialist or a senior assistant. The resuscitation team leader will be informed the ultrasound performer 5 seconds before the check pulse so that he takes a four-chamber view of the heart within 10 seconds of checking the pulse. In the first time, cardiac organized contraction and pericardial effusion are checked and recorded. In the second check pulse, the presence of hypovolemia (right ventricle collapse) and pulmonary embolism (right ventricular enlargement with left ventricular collapse) is checked and recorded, and in the third check pulse, a pneumothorax is checked in the event of a strong clinical suspicion of it.
Main outcome variables
The main outcome of the study is to determine and cure the reversible causes of cardiac arrest and its impact on the final outcome of the patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180129038549N9
Registration date: 2018-10-04, 1397/07/12
Registration timing: registered_while_recruiting

Last update: 2018-10-04, 1397/07/12
Update count: 0
Registration date
2018-10-04, 1397/07/12
Registrant information
Name
Farhad Heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8804
Email address
drfarhadheydari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-11, 1396/09/20
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Accuracy of point-of-care focused sonography in predicting outcome of resuscitation in cardiac arrest patients
Public title
Ultrasound in cardiac arrest
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Cardiac arrest Pulseless electrical activity or asystole rhythm Age over 18 years old
Exclusion criteria:
Failureto perform ultrasound during resuscitation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with Table of random numbers
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.MUI.RES.1396.2.070

Health conditions studied

1

Description of health condition studied
Cardiac arrest
ICD-10 code
I46
ICD-10 code description
Cardiac arrest

Primary outcomes

1

Description
Cardiac Organized Contractions
Timepoint
During resuscitation
Method of measurement
With ultrasound

2

Description
Cardiac tamponade
Timepoint
During resuscitation
Method of measurement
With ultrasound

3

Description
Right ventricle enlargement
Timepoint
During resuscitation
Method of measurement
With ultrasound

4

Description
Left ventricle enlargement
Timepoint
During resuscitation
Method of measurement
With ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Sonography during resuscitation in the check pulse period. During resuscitation, an ultrasound curved array probe (2–4 MHz) placed in the subxiphoid area. The resuscitation team leader will be informed the ultrasound performer 5 seconds before the check pulse so that he takes a four-chamber view of the heart within 10 seconds of checking the pulse. In the first time, cardiac organized contraction and pericardial effusion are checked and recorded. In the second check pulse, the presence of hypovolemia (right ventricle collapse) and pulmonary embolism (right ventricular enlargement with left ventricular collapse) is checked and recorded, and in the third check pulse, a pneumothorax is checked in the event of a strong clinical suspicion of it.
Category
Diagnosis

2

Description
Control group: Performing a classic cardiopulmonary resuscitation
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra hospital
Full name of responsible person
Farhad Heydari
Street address
Alzahra Hospital, Sofeh Ave., Shahid Keshvari Blvd
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3620 2020
Email
drfarhadheydari@gmail.com

2

Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Farhad Heydari
Street address
Kashani Hospital, kashani Street
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3233 0091
Email
drfarhadheydari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjou Javanmard
Street address
Isfahan University of Medical Science, Hezarjrib Street, Isfahan City
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No 7, Aria Building, Sohrevardi Ave.,
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No 7, Aria Building, Sohrevardi Ave.,
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Farhad Heydari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
No 7, Aria Building, Sohrevardi Ave.,
City
Isfahan
Province
Isfehan
Postal code
8177777645
Phone
+98 31 3776 9818
Fax
Email
drfarhadheydari@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
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