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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
Sponsor:
Collaborator:
Department of Health, Generalitat de Catalunya
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

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.


Condition or disease Intervention/treatment Phase
Cardio Respiratory Arrest Other: Training and creation of the Network-CPR Other: Control Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 475 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CPR

Arm Intervention/treatment
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
No intervention




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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).

  5. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Department of Health, Generalitat de Catalunya
Investigators
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Principal Investigator: Cristina Rey-Reñones, Phd IDIAP Jordi Gol
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03828305    
Other Study ID Numbers: P17/075
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jordi Gol i Gurina Foundation:
Out of hospital cardiac arrest
cardiopulmonary resuscitation
automated external defibrillators
emergency medical system services
mobile phone
Primary healt-care
Technology
Additional relevant MeSH terms:
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Apnea
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory