Cardiopulmonary Resuscitation Training Program Based on Quality Control

April 7, 2017 updated by: ANDREKA PETER, Hungarian Institute of Cardiology

Cardiopulmonary Resuscitation Training Program Based on Quality Control in Gottsegen György Hungarian Institute of Cardiology

In a prospective, non-randomized study, all of the basic and advanced cardiopulmonary resuscitations would be analyzed. All resuscitation are planned to be performed by the above mentioned devices according to the recent protocols. The continuous audio-visual feedback and all the data obtained during the resuscitation are intended to develop a better CPR training program in the future.

The downloading of data is planned to occur on the same day of CPR to a data card. After approximately one week all the participant medical persons would receive a detailed case analysis. Elimination of the typical errors is targeted.

Monitored quality indicators

Follow-up of CPR protocol:

elapsed time between turning on device and first chest compression elapsed time between turning on device and first delivered shock elapsed time between turning on device and first delivered shock in case of shockable rhythm compliance with 2 minutes long CPR period recognition of rhythm, recognition of adequate therapy, follow-up of the protocol concerning DC-shock recording the exact moment of the following procedures (with the use of Code Marker button on the defibrillator device) endotracheal intubation drug therapy obtaining intravenous access oxygen therapy

Quality of chest compressions:

depth frequency release compression fraction

Discontinuance of chest compression - cause anf time interval (Code Marker) endotracheal intubation ventilation rhythm analysis and defibrillation obtaining intravenous access

Other data (obtaining with manual recording):

cause of sudden cardiac death initial rhythm exact time of sudden death eyewitness records data of the patient monitoring system (only optional) description of place participant of CPR first detection medical documentation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Sudden cardiac death remains the leading cause of morbidity and mortality and has public health importance. In recent decades, the pathophysiology became better known, however despite the development of medical devices and therapies, significant improvement in outcome was not observed, survival of patients remained low REF1-4.

The resuscitation protocols are based on universal algorithms REF5-6, are valid for all health care practitioners regardless of qualifications, skills. This reanimation paradigm focuses on the basic skills (chest compression, respiration) REF7-8. On the basis of investigations, the most important factors would be: continuous, high-quality chest compressions with the possibly of shortest interruptions REF9, however, the performance of this practice has significant difficulties to meet the expectations REF10.

Without relevant data, the meaningful assessment, follow-up and analysis of resuscitation are difficult, so a substantive case-based training is not feasible.

A reanimation training program on the basis of continuous audio-visual feedback, data and case report would be needed to improve the poor outcome.

A study proved that audio-visual cardiopulmonary resuscitation (CPR) feedback, case analysis and scenario-based training can improve significantly the parameters of basic life support (BLS) and can increase the odds of a better neurological survival status after sudden cardiac arrest outside a hospital - adjusted odds ratio (AOR) 2.7 REF11.

Another study REF12 demonstrated that this method in a hospital environment can improve CPR quality indicators. The so-called Advanced Resuscitation the framework program has also achieved a significant leap from the hospital survival (AOR 2.2, good neurological status AOR 3.0) with similar methods and technology REF13. These results show that an increase in the survival can be achieved with the improvement of resuscitation method and training.

Advanced life support (ALS) service in the Gottsegen György Hungarian Institute of Cardiology is provided by the medical staff of the Cardiology Intensive Care Unit (emergency medical team - EMT).

Our aim is to evolve a continuous quality improvement program with the usage of ZOLL R Series defibrillator device and defibrillator pads with a real-time CPR feedback option and CodeReview case analysis software, and to provide further execution of the program thereafter.

In a prospective, non-randomized study, all of the basic and advanced cardiopulmonary resuscitations would be analyzed. All resuscitation are planned to be performed by the above mentioned devices according to the recent protocols. The continuous audio-visual feedback and all the data obtained during the resuscitation are intended to develop a better CPR training program in the future.

The downloading of data is planned to occur on the same day of CPR to a data card. After approximately one week all the participant medical persons would receive a detailed case analysis. Elimination of the typical errors is targeted.

Monitored quality indicators

Follow-up of CPR protocol:

elapsed time between turning on device and first chest compression elapsed time between turning on device and first delivered shock elapsed time between turning on device and first delivered shock in case of shockable rhythm compliance with 2 minutes long CPR period recognition of rhythm, recognition of adequate therapy, follow-up of the protocol concernig DC-shock recording the exact moment of the following procedures (with the use of Code Marker button on the defibrillatior device) endotracheal intubation drug therapy obtaining intravenous access oxygen therapy

Quality of chest compressions:

depth frequency release compression fraction

Discontinuance of chest compression - cause anf time interval (Code Marker) endotracheal intubation ventilation rhythm analysis and defibrillation obtaining intravenous access

Other data (obtaining with manual recording):

cause of sudden cardiac death initial rhythm exact time of sudden death eyewitness records data of the patient monitoring system (only optional) description of place participant of CPR first detection medical documentation

Participant of the study:

Péter ANDRÉKA Prof. MD, Head of Department, Principal Investigator of study Gábor UZONYI MD, Head of Intensive Care Unit Krisztina SZÜTS MD András CSEPREGI MD Attila KOVÁCS MD Péter TAKÁCS MD András BECK MD Csaba SÁRI MD, Coordinator of study Adrienn MANDZÁK MD Judit POLANECZKY Anna NAGYNÉ LŐKE

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patients who went through basic and advanced cardiopulmonary resusciations would be analyzed

Description

inclusion criteria: all-cause circulatory arrest exclusion criteria: "do not resuscitate" code, age under 18

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
all patients
all of patients who went through basic and advanced cardiopulmonary resuscitations would be analyzed
Device: cardiopulmonary resuscitation with Zoll R Series defibrillator and defibrillator pads with a real-time CPR feedback option and CodeReview case analysis software
cardiopulmonary resuscitation with Zoll R Series defibrillator and defibrillator pads with a real-time CPR feedback option and CodeReview case analysis software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follow-up of CPR protocol
Time Frame: period of cardiopulmonary resuscitation (up to 2 hours)
elapsed time between turning on device and first chest compression elapsed time between turning on device and first delivered shock elapsed time between turning on device and first delivered shock in case of shockable rythm compliance with 2 minutes long CPR period recognition of rythm, recognition of adequate therapy, follow-up of the protocol concernig DC-shock recording the exact moment of the following procedures (with the use of Code Marker button on the defibrillatior device)
period of cardiopulmonary resuscitation (up to 2 hours)
Quality of chest compressions
Time Frame: period of cardiopulmonary resuscitation (up to 2 hours)
depth frequency release compression fraction
period of cardiopulmonary resuscitation (up to 2 hours)
Discontinuance of chest compression - cause anf time interval (Code Marker)
Time Frame: period of cardiopulmonary resuscitation (up to 2 hours)
endotracheal intubation ventilation rythm analysis and defibrillation obtaning intravenous access
period of cardiopulmonary resuscitation (up to 2 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hungarian Institute of Cardiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2017

Primary Completion (Anticipated)

July 31, 2017

Study Completion (Anticipated)

August 31, 2017

Study Registration Dates

First Submitted

March 17, 2017

First Submitted That Met QC Criteria

April 7, 2017

First Posted (Actual)

April 13, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CPRTPBQC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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