Cardiac Arrest and Intra Osseous Infusion (ACCIO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01803971
First received: January 16, 2013
Last updated: September 26, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Cardiac Arrest
Other: Obtention of vascular access in out-of-hospital cardiac arrest patients according to the current strategy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Obtaining Vascular Access (Venous or Intraosseous) During Cardiac Arrest in Out-of-hospital Care: Delays and Failure Risk Factors

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • functional vascular access [ Time Frame: at inclusion (day 0) ] [ Designated as safety issue: No ]
    time for obtaining a functional vascular access from the beginning of out-of-hospital cardiac arrest management


Enrollment: 200
Study Start Date: June 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803971

Locations
France
CHU Bordeaux
Bordeaux, France
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Study Chair: Paul PEREZ, MD, PhD University Hospital Bordeaux, France
Principal Investigator: Bruno SIMONNET, MD University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01803971     History of Changes
Other Study ID Numbers: CHUBX 2011/13, 2010/080
Study First Received: January 16, 2013
Last Updated: September 26, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
cardiac arrest
peripheral venous access
intraosseous access

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014