Cardiac Arrest and Intra Osseous Infusion (ACCIO)

Obtaining Vascular Access (Venous or Intraosseous) During Cardiac Arrest in Out-of-hospital Care: Delays and Failure Risk Factors

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Obtention of vascular access in out-of-hospital cardiac arrest patients according to the current strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France
    • CHU Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional vascular access	time for obtaining a functional vascular access from the beginning of out-of-hospital cardiac arrest management	at inclusion (day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Study Chair: Paul PEREZ, MD, PhD, University Hospital Bordeaux, France; Principal Investigator: Bruno SIMONNET, MD, University Hospital Bordeaux, France

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: March 1, 2013
• First Posted (Estimate): March 4, 2013

Study Record Updates

• Last Update Posted (Estimate): September 27, 2013
• Last Update Submitted That Met QC Criteria: September 26, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: cardiac arrest; peripheral venous access; intraosseous access
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: CHUBX 2011/13; 2010/080 (Other Identifier: USMR / Edelweiss)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No