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Cardiac Arrest and Intra Osseous Infusion (ACCIO)

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Obtention of vascular access in out-of-hospital cardiac arrest patients according to the current strategy
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, peripheral venous access, intraosseous access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

vascular access in out-of-hospital cardiac arrest patients

Arm Description

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

Outcomes

Primary Outcome Measures

functional vascular access
time for obtaining a functional vascular access from the beginning of out-of-hospital cardiac arrest management

Secondary Outcome Measures

Full Information

First Posted
January 16, 2013
Last Updated
September 26, 2013
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT01803971
Brief Title
Cardiac Arrest and Intra Osseous Infusion
Acronym
ACCIO
Official Title
Obtaining Vascular Access (Venous or Intraosseous) During Cardiac Arrest in Out-of-hospital Care: Delays and Failure Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
cardiac arrest, peripheral venous access, intraosseous access

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vascular access in out-of-hospital cardiac arrest patients
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Obtention of vascular access in out-of-hospital cardiac arrest patients according to the current strategy
Intervention Description
Current strategy of obtention of a vascular access : first attempt by peripheral venous access and if failure switch to intraosseous route
Primary Outcome Measure Information:
Title
functional vascular access
Description
time for obtaining a functional vascular access from the beginning of out-of-hospital cardiac arrest management
Time Frame
at inclusion (day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul PEREZ, MD, PhD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bruno SIMONNET, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France

12. IPD Sharing Statement

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Cardiac Arrest and Intra Osseous Infusion

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