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Cardiac Arrest and Intra Osseous Infusion

NCT ID: NCT01803971

Last Updated: 2013-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-03-31

Brief Summary

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the international recommendations don't explain the place of the intraosseous infusion in the reanimation of adult cardiac arrest; the goal of this preliminary study is to inform the delay for obtaining a vascular access by evaluation of a current strategy (using intraosseous infusion after one peripheral venous access failure) and to determine the potential failure risk factors of venous access.

Detailed Description

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In 2010, the European Resuscitation Council and the International Liaison Commitee on Resuscitation have made new recommendations about management of cardiac arrest. The intraosseous infusion was described as an alternative to the peripheral venous access, before the intra tracheal way for adrenaline administration. But this work doesn't specify the delay and the circumstance for this use: time to obtain a vascular access, number of failure, difficulty to obtain a venous access. Furthermore the recent improvements in intraosseous devices may make it relevant to compare intra osseous infusion and venous access in first intention in adult's cardiac arrest in view of the significant number of venous failures and of the subsequent delay of adrenaline administration.

The goal of this preliminary study is to inform the delay to obtain a vascular access by evaluation of a current care (using intravenous infusion after one peripheral venous access failure) and to determine the potential failure's risk factors of venous access.

Main objective: estimate the delay to obtain an effective vascular access (peripheral venous access, intra osseous infusion, central venous access) in resuscitation of adult's cardiac arrest by out of hospital care unit according to the international recommendations.

Study design: monocentric prospective cohort of consecutive patients presenting with out-of-hospital cardiac arrest.

Conditions

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Cardiac Arrest

Keywords

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cardiac arrest peripheral venous access intraosseous access

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vascular access in out-of-hospital cardiac arrest patients

Obtention of vascular access according to the current strategy, ie after one unsuccessful attempt to obtain a peripheral venous access, use of an intra osseous device

Group Type EXPERIMENTAL

Obtention of vascular access in out-of-hospital cardiac arrest patients according to the current strategy

Intervention Type OTHER

Current strategy of obtention of a vascular access : first attempt by peripheral venous access and if failure switch to intraosseous route

Interventions

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Obtention of vascular access in out-of-hospital cardiac arrest patients according to the current strategy

Current strategy of obtention of a vascular access : first attempt by peripheral venous access and if failure switch to intraosseous route

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years old or over
* patients insured by social security
* cardiac arrest (all causes) with mobilisation of a intensive mobile care unit in primary intervention
* medical resuscitation indicated

Exclusion Criteria

* pregnancy
* contraindication osseous infusion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul PEREZ, MD, PhD

Role: STUDY_CHAIR

University Hospital Bordeaux, France

Bruno SIMONNET, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bordeaux, France

Locations

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CHU Bordeaux

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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2010/080

Identifier Type: OTHER

Identifier Source: secondary_id

CHUBX 2011/13

Identifier Type: -

Identifier Source: org_study_id