NCT03828305: Smartwatch

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

Completed NA Last updated 29 July 2020

What this trial tests

NA trial testing Training and creation of the Network-CPR in Cardio Respiratory Arrest in 475 participants. Completed in 31 December 2019.

Timeline

1 June 2016

Primary endpoint
1 June 2016

31 December 2019

Quick facts

Lead sponsor	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	475
Start date	1 June 2016
Primary completion	1 June 2016
Estimated completion	31 December 2019

Drugs / interventions tested

• Training and creation of the Network-CPR
• Control Group — full drug profile →

Conditions studied

• Cardio Respiratory Arrest — all drugs for Cardio Respiratory Arrest →

Sponsor

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina — full company profile →

Who can join

18 and older, any sex, with Cardio Respiratory Arrest. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effectiveness of a network of automatically activated trained volunteers on the reduction of cardiopulmonary resuscitation manoueuvers initiation time: study protocol.
   Del Pozo A, Villalobos F, Rey-Reñones C, Granado E, et al · · 2019 · cited 5× · PMID 31088520 · DOI 10.1186/s12889-019-6896-9