Effectiveness of a Network of Trained Volunteers Automatically Activated, on the Reduction of the Start Time of Cardiopulmonary Resuscitation Maneuvers. Study Protocol. (Smartwatch)
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|ClinicalTrials.gov Identifier: NCT03828305|
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : July 29, 2020
Background Cardiorespiratory arrest (CRA) is a health emergency with high mortality. Mortality could depends on the start time of cardiopulmonary resuscitation (CPR) maneuvers (and the quality of its performance) and the use of the automated external defibrillator (AED).
Methods / design The aim of the study is to determine the effectiveness of a network of volunteers automatically activated by smartwatch and smartphone, on the reduction of the start time of cardiopulmonary resuscitation maneuvers. It is developed in four phases: 1) validation of an application (App) for smartwatch developed to automatically generate a health alert in case of out-of-hospital cardiorespiratory arrest (OHCA); 2) training course in basic CPR maneuvers and use of the AED aimed at the civilian population; 3) creation of a network of volunteers trained in CPR and using the AED that covers the city; 4) simulation study in which members of the network of volunteers will be activated automatically through their smartphone to attend simulated OHCA. 134 activations of the alert will be made. On 67 occasions the alert will be directed to the emergency health services and to the network of volunteers (intervention group). On 67 occasions the alert will be directed to the emergency health services (control group). The arrival time of the first rescuer, category of the first rescuer (emergency services or network of volunteers), start time of the maneuvers and competence in the performance of the maneuvers will be recorded.
Discussion Training in CPR maneuvers is recommended for the civilian population and especially for relatives and close persons of people with heart disease to reduce the start time of CPR and improve survival rates due to CRA. This study aims to observe that the start time of CPR maneuvers and use of the AED will be lower in the intervention group than in the control group.
|Condition or disease||Intervention/treatment||Phase|
|Cardio Respiratory Arrest||Other: Training and creation of the Network-CPR Other: Control Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||475 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This clinical trial aims to determine the effectiveness of a network of volunteers trained in CPR maneuvers and using the AED connected through an application (App) for smartwatch, which allows automatic activation in case of out-of-hospital cardiorespiratory arrest (OHCA), on the start time of the CPR maneuvers and use of the AED.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effectiveness of a Network of Trained Volunteers Automatically Activated, on the Reduction of the Start Time of Cardiopulmonary Resuscitation Maneuvers. Study Protocol.|
|Actual Study Start Date :||June 1, 2016|
|Actual Primary Completion Date :||June 1, 2016|
|Actual Study Completion Date :||December 31, 2019|
Experimental: Training and creation of the Network-CPR
Training in CPR
Other: Training and creation of the Network-CPR
Training and creation of the Network-CPR that will cover the city. This network will be created with certain population groups that are routinely in contact with susceptible persons of OHCA (police, firemen, teaching staff, health personnel, merchants, pharmacists, university students, etc.), in addition, relatives of people with heart disease will be included. In the case of elderly people who are alone, they will include their neighbors or caregivers. In the city, there are 2,105 people with heart disease susceptible to OHCA. The research team and the health personnel of the participating primary care centers (PCC) will offer training courses on basic CPR maneuvers and use of the AED, following the protocol of the Center Català de Ressucitació (CCR). The training is aimed at training 430 people (20% of the relatives of people with heart disease) and will be made by trainers accredited by the CCR. There will be a total of 30 sessions with groups of approximately 15 people.
Active Comparator: Control Group
Primary Care Center Emergency Personnel
Other: Control Group
- Start time of the maneuvers (Tim) [ Time Frame: 6 months ]time (minutes and seconds) elapsed between the start of the simulated CRA (T0) and the start of the CPR maneuvers (T2b or T3b in case of arrival of PCEC team or Network-CPR , respectively). It is considered that the maneuvers stars when the chest compressions are started in the manikin.
- Time of start of the use of the AED (Tid) [ Time Frame: 6 months ]time elapsed between the start of the simulated CRA (T0) and the start of the use of the AED (T2d or T3d in case of arrival of the PCEC team or Netwrok-CPR, respectively) . It is considered that the use of the AED starts when the patches are placed on the thorax of the manikin.
- Response time of the PCCE team (Trc) [ Time Frame: 6 months ]time between the start of the simulated CRA (T0) and the arrival of the PCEC team (T2).
- Response time of the Network-CPR (Trr) [ Time Frame: 6 months ]time between the start of the simulated CRA (T0) and the arrival of the Network-CPR (T3).
- AED arrival time (TllD) [ Time Frame: 6 months ]Time elapsed between the start of the simulated CRA (T0) and the arrival of the AED (T2c or T3c, in case of arrival of PCEC team or Network-CPR, respectively). It is necessary to register who brings the AED, members of the Network-CPR, personnel of the PCEC team or an external person to whom assistance has been requested.
- Evaluation of the competence of the members of the Network-CPR [ Time Frame: 6 months ]Item score: 1p per item. a) safe approach; b) evaluation of the state of consciousness; c) opening of the airway; d) spontaneous breathing check; e) ask for help; f) chest compressions (quality); g) frequency of comprehensions; h) two insufflations (quality); i) alternation compressions/insufflations. It will be considered that you have performed a correct CPR maneuver if 8 of the 9 items evaluated are performed correctly
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828305
|Principal Investigator:||Cristina Rey-Reñones, Phd||IDIAP Jordi Gol|