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Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

Sponsor
Singapore General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02088736
Collaborator
Singapore Civil Defence Force (Other)
1,103
Enrollment
1
Location
2
Arms
36
Actual Duration (Months)
30.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Intraosseous
  • Device: Intravenous
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
1103 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Intraosseous and Intravenous Access for Cardiac Arrest Treatment in Emergency Ambulances In Singapore
Actual Study Start Date :
Jun 1, 2014
Actual Primary Completion Date :
Jan 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intravenous and Intraosseous

'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
Other Names:
  • EZIO

    		•
    Experimental: Intravenous

    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
    Other Names:
  • IV Cannula

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Insertion success rate [90 secs]

    2. Number of patients administered 1st dose [90 secs]

    3. Survival outcome [up to 30 days]

    4. Time taken for 1st dose of adrenaline given [90 secs]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Singapore Civil Defence Force Singapore Singapore

    Sponsors and Collaborators

    • Singapore General Hospital
    • Singapore Civil Defence Force

    Investigators

    • Principal Investigator: Kenneth Boon Kiat Tan, MBBS, Singapore General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Singapore General Hospital
    ClinicalTrials.gov Identifier:
    NCT02088736
    Other Study ID Numbers:
    • CIRB 2013/676/C
    • NMRC/CNIG/1110/2013
    First Posted:
    Mar 17, 2014
    Last Update Posted:
    Oct 28, 2019
    Last Verified:
    Oct 1, 2019
    Additional relevant MeSH terms:
    Heart Arrest

    Study Results

    No Results Posted as of Oct 28, 2019