Effectiveness of a Network of Trained Volunteers Automatically Activated, on the Reduction of the Start Time of Cardiopulmonary Resuscitation Maneuvers. Study Protocol.

NCT03828305 | Completed DMC

• 1 other identifier: P17/075
• Study Type: interventional
• Target: 475
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cardio Respiratory Arrest

Keywords

Out of hospital cardiac arrest; cardiopulmonary resuscitation; automated external defibrillators; emergency medical system services; mobile phone; Primary healt-care; Technology

Outcome Measures

Primary Outcomes (5)

• Start time of the maneuvers (Tim)

  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.

  6 months

• Time of start of the use of the AED (Tid)

  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.

  6 months

• Response time of the PCCE team (Trc)

  time between the start of the simulated CRA (T0) and the arrival of the PCEC team (T2).

  6 months

• Response time of the Network-CPR (Trr)

  time between the start of the simulated CRA (T0) and the arrival of the Network-CPR (T3).

  6 months

• AED arrival time (TllD)

  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.

  6 months

Secondary Outcomes (1)

• Evaluation of the competence of the members of the Network-CPR

  6 months

Study Arms (2)

Training and creation of the Network-CPR

EXPERIMENTAL

Training in CPR

Other: Training and creation of the Network-CPR

Control Group

ACTIVE COMPARATOR

Primary Care Center Emergency Personnel

Other: Control Group

Interventions

Training and creation of the Network-CPR OTHER

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.

Training and creation of the Network-CPR

Control Group OTHER

No intervention

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Qualification of suitable, based on the evaluation of the competences during the course.
• Being over 18 years.
• Have an smartphone with Android operating system.
• The signing of the informed consent document
• The installation of the App on the smartphone.

You may not qualify if:

• Qualification of no-suitable, based on the evaluation of the competences during the course.
• No-being over 18 years.
• Have an smatphone with an operating system diferent from Android.
• no-singning of the informed consent document.
• The no-intallation of the App on the smartphone.
• No understood the language.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Department of Health, Generalitat de Catalunya: collaborator

Related Publications (1)

• Del Pozo A, Villalobos F, Rey-Renones C, Granado E, Sabate D, Poblet C, Calvet A, Basora J, Castro A, Flores G. Effectiveness of a network of automatically activated trained volunteers on the reduction of cardiopulmonary resuscitation manoueuvers initiation time: study protocol. BMC Public Health. 2019 May 14;19(1):572. doi: 10.1186/s12889-019-6896-9.

  PMID: 31088520 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Cristina Rey-Reñones, Phd

  Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 4, 2019
• Study Start: June 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: December 31, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07