Clinical trial NCT03112460: Cardiopulmonary Resuscitation Training Program Based on Quality Control
Official title: Cardiopulmonary Resuscitation Training Program Based on Quality Control in Gottsegen György Hungarian Institute of Cardiology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiopulmonary Resuscitation
Keywords: Cardiopulmonary Resuscitation
Lead sponsor: Hungarian Institute of Cardiology
Sponsor class: OTHER_GOV
First posted: 2017-04-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients who went through basic and advanced cardiopulmonary resusciations would be analyzed

Brief summary: 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

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

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

Primary outcomes:
measure: Follow-up of CPR protocol
timeFrame: period of cardiopulmonary resuscitation (up to 2 hours)
measure: Quality of chest compressions
timeFrame: period of cardiopulmonary resuscitation (up to 2 hours)
measure: Discontinuance of chest compression - cause anf time interval (Code Marker)
timeFrame: period of cardiopulmonary resuscitation (up to 2 hours)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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