Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest
Condition: Cardiac Arrest
MeSH terms: Heart Arrest
Study type: Interventional

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.
    

Detailed description: 
      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.

      Methods This will be a randomized controlled trial conducted within Mecklenburg County by the
      Mecklenburg County EMS Agency (MEDIC). The study population includes all adult (greater than
      18 years of age) cardiac arrest patients of a medical etiology upon whom resuscitative
      efforts are initiated.

      Patient Care Protocols Prehospital protocols for adult cardiac arrest patients within
      Mecklenburg County state that all first responders follow advanced cardiac life support
      (ACLS) algorithms during cardiopulmonary resuscitation. Current MEDIC protocols specify that
      initial vascular access be obtained by paramedics via either tibial or humeral IO needle
      insertion, followed by peripheral IV for secondary access. This study will randomize initial
      vascular access to a humeral IO, tibial IO, or peripheral IV.

      Once paramedics arrive on-scene, they will take a pack from the ambulance containing all
      necessary supplies to begin resuscitation. These packs are already present on each ambulance
      in Mecklenburg County and contain an EZ-IO drill, IO needles, ACLS medications, and KING LTD
      airway device. For the purposes of this study, peripheral IV start kits will be added to
      these resuscitation packs at the start of study implementation.

      Randomization Process

      150 note cards will be prepared in advance and labeled with a vascular access method. [50
      cards with "Tibial IO", 50 cards "Humeral IO", 50 cards with "Peripheral IV"] Each note card
      will be sealed in a blank, numbered envelope. A master list will be prepared in advance
      according to envelope number indicating which vascular access method was placed in each
      numbered envelope. This list will only be available to the MEDIC Quality Assurance/Quality
      Improvement (QA/QI) personnel responsible for paramedic debriefing and recirculation of
      unused envelopes.

      Sealed envelopes will then be shuffled and placed at the MEDIC circulation window where
      resuscitation packs and ambulance equipment are distributed daily.

      Each crew will randomly select and open an envelope prior to every shift. By opening the
      envelope at the start of the day, this will eliminate the possibility of envelopes being left
      in the ambulance unit or lost at the scene, as well as prevent delays with patient care.

      The envelope number will be recorded at the circulation window indicating the specific MEDIC
      ambulance unit and assigned crew.

      The vascular access route selected will apply to the crew's first cardiac arrest of the day.

      Resuscitation Protocol

      Paramedics will conduct the resuscitation according to existing procedure, and will proceed
      with vascular access as follows depending on the method selected by randomization:

      Tibial IO 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.

      Humeral IO 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.

      Peripheral IV 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.

      Since it is extremely rare for any crew to conduct more than one cardiac arrest on a given
      day, the randomized vascular access method will only apply to the first cardiac arrest of the
      day. As crews do not return to the distribution center until the end of a shift (12 hours),
      it will be impossible to select additional envelopes for subsequent patient encounters.
      Paramedics will proceed with vascular access per current MEDIC prehospital protocols for any
      further cardiac arrest resuscitations that day.

      If there is a contraindication to the vascular access site selected such as extremity
      amputations, orthopedic hardware, skin infection, or traumatic injuries, paramedics will
      proceed to the next insertion site as per the above protocol. For instance, if a patient with
      bilateral lower extremity amputations is randomized to a tibial IO insertion site, paramedics
      will classify this as a failed attempt and proceed to humeral IO, then peripheral IV as
      stated above. For patients with isolated skin infections or orthopedic hardware involving one
      extremity, paramedics will select the unaffected extremity for the first attempt. Any
      unforeseen circumstances will be addressed according to the paramedics' discretion and
      reported to the primary investigator immediately. Such occurrences will be included in the
      final data analysis for this study.
    

Intervention name(s): Intravenous access during OHCA; Humeral IO insertion; TIbial IO insertion
Intervention type(s): Device; Device; Device
Intervention description(s): 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.; 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.; 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intraosseous infusion; Emergency Medical Services