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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

Tracking Information
First Submitted Date  ICMJE March 11, 2014
First Posted Date  ICMJE March 17, 2014
Last Update Posted Date October 28, 2019
Actual Study Start Date  ICMJE June 2014
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
Return of Spontaneous Circulation Rate [ Time Frame: monitoring 10mins ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2014)
  • Insertion success rate [ Time Frame: 90 secs ]
  • Number of patients administered 1st dose [ Time Frame: 90 secs ]
  • Survival outcome [ Time Frame: up to 30 days ]
  • Time taken for 1st dose of adrenaline given [ Time Frame: 90 secs ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intraosseous vs Intravenous Access for Cardiac Arrest Treatment
Official Title  ICMJE Clinical Evaluation of Intraosseous and Intravenous Access for Cardiac Arrest Treatment in Emergency Ambulances In Singapore
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Cardiac Arrest
Intervention  ICMJE
  • Device: Intraosseous
    Other Name: EZIO
  • Device: Intravenous
    Other Name: IV Cannula
Study Arms  ICMJE
  • 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.
    Intervention: Device: Intraosseous
  • 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.
    Intervention: Device: Intravenous
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2018)
1103
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2014)
400
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date January 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02088736
Other Study ID Numbers  ICMJE CIRB 2013/676/C
NMRC/CNIG/1110/2013 ( Other Identifier: MOH NMRC, Singapore )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Singapore General Hospital
Study Sponsor  ICMJE Singapore General Hospital
Collaborators  ICMJE Singapore Civil Defence Force
Investigators  ICMJE
Principal Investigator: Kenneth Boon Kiat Tan, MBBS Singapore General Hospital
PRS Account Singapore General Hospital
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP