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
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring cardiac arrest, peripheral venous access, intraosseous access
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
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
NCT ID
NCT01803971
First Posted
January 16, 2013
Last Updated
September 26, 2013
Sponsor
University Hospital, Bordeaux
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
Learn more about this trial
Cardiac Arrest and Intra Osseous Infusion
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