Cardiac ArrestNCT01119807
Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest
A study testing Intravenous access during OHCA, Humeral IO insertion and TIbial IO insertion in people with Cardiac Arrest, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Intravenous access during OHCA, Humeral IO insertion and TIbial IO insertion
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All cardiac arrests of a medical nature in patients greater than or equal to 18 years of age occuring in Mecklenburg county, NC.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mecklenburg EMS Agency
Charlotte, North Carolina, 28208
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Being tested
- Intravenous access during OHCA, Humeral IO insertion, TIbial IO insertion
- Keywords
- Intraosseous infusion, Emergency Medical Services
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous access during OHCADevice
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.
Humeral IO insertionDevice
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.
TIbial IO insertionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intra Venous Access | Experimental | Patient initially receives IV access during resuscitation Receives: Device: Intravenous access during OHCA |
| Humeral IO | Experimental | Patient receives humeral IO access during resuscitation Receives: Device: Humeral IO insertion |
| Tibial IO | Active comparator | Patient receives tibial IO access during resuscitation Receives: Device: TIbial IO insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Studnek, PhD, Study director, Mecklenburg EMS Agency
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119807
- Sponsor's protocol ID
- MeckIO2010
- Status last verified
- Nov 2021
- First submitted
- 6 May 2010
- Last updated
- 3 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21856044
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraosseous Versus Intravenous Vascular Access During Cardiac Arrest
- ClinicalTrials.gov ID
- NCT01119807
- Acronym / sponsor ID
- MeckIO2010
- Conditions
- Cardiac Arrest
- Keywords
- Intraosseous infusion, Emergency Medical Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Posted 3 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intra Venous Access | Experimental | Device: Intravenous access during OHCAPatient initially receives IV access during resuscitation |
| Humeral IO | Experimental | Device: Humeral IO insertionPatient receives humeral IO access during resuscitation |
| Tibial IO | Active comparator | Device: TIbial IO insertionPatient receives tibial IO access during resuscitation |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All cardiac arrests of a medical nature in patients greater than or equal to 18 years of age occuring in Mecklenburg county, NC.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous access during OHCAFirst 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. | Device | Intra Venous Access |
| Humeral IO insertionFirst 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. | Device | Humeral IO |
| TIbial IO insertionFirst 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. | Device | Tibial IO |
Primary outcome
First Attempt Success Rate Between the Tibial IO, Humeral IO, and Peripheral IV.
Time frame: 1 day
This measure will be assessed on the day an individual experiences cardiac arrest and will not be followed upon admission to the emergency department.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21856044Reades 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Studnek, PhD study director
Mecklenburg EMS Agency
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous access during OHCA, Humeral IO insertion and TIbial IO insertion in people with Cardiac Arrest, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Attempt Success Rate Between the Tibial IO, Humeral IO, and Peripheral IV. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01119807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.