Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

Study Overview
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Brief Summary
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In patients with out-of-hospital cardiac arrest in Singapore, investigators aim to assess the benefit of introducing a resuscitation protocol including the use of intravenous (IV) access and/or intraosseous (IO) vascular access in the pre-hospital setting. The assumption is that low vascular access rates could be due to difficulty of setting IV cannulas in the field due to certain factors like poor lighting or space constraints. Thus, by introducing a protocol including IO access for difficult IV cases, success rates for vascular access will be higher and this might lead to higher survival rates. This will be a study comparing 'IV+IO' and 'IV alone' protocols in patients with cardiac arrest managed by Singapore Civil Defence Force (SCDF) emergency ambulance service. The trial will recruit 400 patients over 1 year. Each of the 30 SCDF ambulances will provide both 'IV+IO' and 'IV alone' treatments in 2 consecutive phases of 6-months in order to allow for all ambulance crew a chance to be trained on usage of IO. Currently, IO insertion is the accepted standard of care in Singapore General Hospital, Department of Emergency Medicine.

Detailed Description
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Primary objectives: In adult and paediatric patients with Out-of-Hospital Cardiac Arrest (OHCA) in Singapore, investigators aim to evaluate the incremental benefit of introducing a resuscitation protocol including the use of intravenous (IV) access and/or intraosseous (IO) vascular access compared to protocols with only intravenous (IV) access by SCDF paramedics in the pre-hospital setting on the return of spontaneous circulation (ROSC) rates. Secondary Objective: To compare the success rates of vascular access with IV access and/or IO insertion compared to that with intravenous (IV) access alone by SCDF paramedics in the pre-hospital setting. To compare the rates of successful 1st dose adrenaline given in the field to cardiac arrest patients in IV+IO and IV groups and whether this translates into a higher survival rate at 30 days. To determine the cost benefit of introducing IO access to the emergency ambulance service for OHCA. Hypothesis: In adult and paediatric patients with Out-of-Hospital Cardiac Arrest (OHCA) in Singapore, the hypothesis is that low vascular access rates could be due to difficulty of setting IV cannulas in the field due to certain factors like poor lighting or space constraints. Thus, by introducing a protocol including IO access for difficult IV cases, success rates for vascular access will be higher and this might lead to a higher ROSC and survival rates.

Official Title
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Clinical Evaluation of Intraosseous and Intravenous Access for Cardiac Arrest Treatment in Emergency Ambulances In Singapore

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: Intraosseous
* Device: Intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cardiac arrest (medical or traumatic) Intravenous fluids or medications needed Exclusion Criteria: Adult needle (weight ≥ 40 kg) Paediatric needle (weight 3 - 39 kg)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous and Intraosseous<br>'IV + IO' Intravenous fluids or medications needed and a peripheral IV given 2 attempts or 90 seconds. If IV is unsuccessful, IO will attempt at the Primary site (proximal tibia). If IO is unsuccessful at scene, 2nd attempt can be done in the ambulance. Adrenaline will be delivered as according to protocol. | Device: Intraosseous<br> <br> * Other names: EZIO;|
| Experimental: Intravenous<br>Intravenous fluids or medications needed and a peripheral IV given 2 attempts or 90 seconds. If 1st IV is unsuccessful at scene, 2nd IV attempt can be done in the ambulance. Adrenaline will be delivered according to protocol. | Device: Intravenous<br> <br> * Other names: IV Cannula;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any Return of Spontaneous Circulation Rate (ROSC) | Any ROSC including transient or intermittent during pre- or in-hospital | At scene to hospital (about 2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion success rate |  | 90 secs | 
| Number of patients administered 1st dose |  | 90 secs | 
| Survival outcome |  | up to 30 days | 
| Time taken for 1st dose of adrenaline given |  | 90 secs |