Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest

NCT01119807 | Completed Results DMC

• 1 other identifier: MeckIO2010
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study will be to compare humeral and tibial IO needle insertions to peripheral IV access during cardiac arrest. Hypothesis There is a difference in first attempt success of tibial IOs compared to humeral IOs or peripheral IV among cardiac arrest patients. This was a randomized trial of adult patients experiencing a medical OOHCA where resuscitation efforts were initiated. Patients were randomized to 1 of 3 routes of vascular access. Prior to every shift, paramedics were distributed a randomly selected note card indicating the prescribed route for vascular access: tibial IO, humeral IO, or peripheral IV. The selected method applied to the first attempt at vascular access only. Paramedics received intensive training and exposure to all three methods prior to study initiation. The primary outcome was first attempt success defined as secure needle position in the marrow cavity or a peripheral vein with normal fluid flow. Needle dislodgement during resuscitation was counted as a failure to maintain vascular access. In order to detect a statistical difference in the frequency of first attempt success a minimum of 50 patients for each arm of the study were needed.

Conditions

Cardiac Arrest

Keywords

Intraosseous infusion; Emergency Medical Services

Outcome Measures

Primary Outcomes (1)

• First Attempt Success Rate Between the Tibial IO, Humeral IO, and Peripheral IV.

  This measure will be assessed on the day an individual experiences cardiac arrest and will not be followed upon admission to the emergency department.

  1 day

Study Arms (3)

Intra Venous Access

EXPERIMENTAL

Patient initially receives IV access during resuscitation

Device: Intravenous access during OHCA

Humeral IO

EXPERIMENTAL

Patient receives humeral IO access during resuscitation

Device: Humeral IO insertion

Tibial IO

ACTIVE COMPARATOR

Patient receives tibial IO access during resuscitation

Device: TIbial IO insertion

Interventions

Intravenous access during OHCA DEVICE

First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.

Intra Venous Access

Humeral IO insertion DEVICE

First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.

Humeral IO

TIbial IO insertion DEVICE

First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.

Tibial IO

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All cardiac arrests of a medical nature in patients greater than or equal to 18 years of age occuring in Mecklenburg county, NC.

You may not qualify if:

• Traumatic cardiac arrests - different prehospital protocols exist for resuscitations involving traumatic arrests (i.e. motor vehicle accidents, motorcycle accidents, falls, and penetrating injuries including stabbings and gunshot wounds).
• Cardiac arrests due to hemorrhage - for the purposes of this study, such arrests are not considered to be of a "medical etiology" since massive blood loss is the contributing factor and only rapid volume resuscitation is indicated.
• Cardiac arrests involving children or young adults - any patient less than 18 years of age will be excluded as different prehospital protocols exist for children in cardiac arrest. Age verification will occur upon data collection using patient date of birth when available. Any data collected from a patient found to be less than 18 years of age after resuscitation, will also be excluded from data analysis.
• Patients with established vascular access prior to cardiac arrest - patients who deteriorate during transport into cardiac arrest but already have a peripheral IV or IO needle established will be excluded from the study. Randomization cannot be applied to these encounters as vascular access has already been selected and documentation by a sole provider is not possible during transport.
• Patients with a Do Not Resuscitate (DNR) - in some circumstances, cardiopulmonary resuscitation is initially performed on patients until a DNR order is produced. These patients will be excluded from the study as the full protocol cannot be implemented.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Mecklenburg EMS Agency

Charlotte, North Carolina, 28208, United States

Location

Related Publications (1)

• Reades R, Studnek JR, Vandeventer S, Garrett J. Intraosseous versus intravenous vascular access during out-of-hospital cardiac arrest: a randomized controlled trial. Ann Emerg Med. 2011 Dec;58(6):509-16. doi: 10.1016/j.annemergmed.2011.07.020.

  PMID: 21856044 RESULT

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jonathan R Studnek PhD
• Organization: Mecklenburg EMS Agency

jonst@medic911.com

7049436046

Study Officials

• Jonathan Studnek, PhD

  Mecklenburg EMS Agency

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 10, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 3, 2022
• Results First Posted: June 3, 2022

Record last verified: 2021-11

Locations

US (1)