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Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02088736
Enrollment
1103
Registered
2014-03-17
Start date
2014-06-30
Completion date
2017-06-30
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Brief summary

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

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.

Interventions

Sponsors

Singapore Civil Defence Force
CollaboratorOTHER
Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Any Return of Spontaneous Circulation Rate (ROSC)At scene to hospital (about 2 hours)Any ROSC including transient or intermittent during pre- or in-hospital

Secondary

MeasureTime frame
Insertion success rate90 secs
Number of patients administered 1st dose90 secs
Survival outcomeup to 30 days
Time taken for 1st dose of adrenaline given90 secs

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026