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Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

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ClinicalTrials.gov Identifier: NCT02088736
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : October 28, 2019
Sponsor:
Collaborator:
Singapore Civil Defence Force
Information provided by (Responsible Party):
Singapore General Hospital

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
Cardiac Arrest 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.

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Study Type : Interventional  (Clinical Trial)
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 : June 2014
Actual Primary Completion Date : January 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

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 Name: 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 Name: IV Cannula




Primary Outcome Measures :
  1. Any Return of Spontaneous Circulation Rate (ROSC) [ Time Frame: 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 [ Time Frame: 90 secs ]
  2. Number of patients administered 1st dose [ Time Frame: 90 secs ]
  3. Survival outcome [ Time Frame: up to 30 days ]
  4. Time taken for 1st dose of adrenaline given [ Time Frame: 90 secs ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088736


Locations
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Singapore
Singapore Civil Defence Force
Singapore, Singapore
Sponsors and Collaborators
Singapore General Hospital
Singapore Civil Defence Force
Investigators
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Principal Investigator: Kenneth Boon Kiat Tan, MBBS Singapore General Hospital
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Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT02088736    
Other Study ID Numbers: CIRB 2013/676/C
NMRC/CNIG/1110/2013 ( Other Identifier: MOH NMRC, Singapore )
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases