NCT02711748

Brief Summary

The study aims to assess the regularity of the proceedings in the case of a patient with bradycardia ECG.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

29 days

First QC Date

February 22, 2016

Last Update Submit

March 16, 2016

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

  • Questionnaire to assess effectiveness of the rhythm recognition and participants' knowledge on life-threatening rhythms

    The effectiveness of the rhythm recognition. participants knowledge on life-threatening rhythms

    intraoperative

Secondary Outcomes (1)

  • Time to take proper action

    intraoperative

Study Arms (2)

Bradycardia

EXPERIMENTAL

Treatment In case of bradycardia. The patient unconscious, breathing preserved in ECG - bradycardia 40 / min with pulse.

Device: electrostimulation

PEA

EXPERIMENTAL

In case of bradycardia. The patient unconscious, not breathing, the ECG - bradycardia 30 / min - no pulse. Pulseless electrical activity

Device: cardiopulmonary resuscitation

Interventions

electrostimulationDEVICE

Electrostimulation using manual defibrillator

Bradycardia
cardiopulmonary resuscitationDEVICE

CPR according to guidelines of European Resuscitation Council. Cardiopulmonary resuscitation using manual defibrillator

PEA

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • give voluntary consent to participate in the study
  • maximum 1 year of work experience in medicine
  • paramedics, nurses, physicians

You may not qualify if:

  • not meet the above criteria
  • wrist or low back diseases
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Warsaw, Department of Emergency Medicine

Warsaw, Masovia, 02-005, Poland

RECRUITING

MeSH Terms

Conditions

Bradycardia

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ResuscitationEmergency TreatmentTherapeutics

Central Study Contacts

Lukasz Szarpak, PhD

CONTACT

+48500186225lukasz.szarpak@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lukasz Szarpak

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 17, 2016

Study Start

February 1, 2016

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

PL(1)