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Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

Primary Purpose

Cardiac Arrest

Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Intraosseous
Intravenous
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Singapore Civil Defence Force

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Intravenous and Intraosseous

Intravenous

Arm Description

'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.

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.

Outcomes

Primary Outcome Measures

Any Return of Spontaneous Circulation Rate (ROSC)
Any ROSC including transient or intermittent during pre- or in-hospital

Secondary Outcome Measures

Insertion success rate
Number of patients administered 1st dose
Survival outcome
Time taken for 1st dose of adrenaline given

Full Information

First Posted
March 11, 2014
Last Updated
October 23, 2019
Sponsor
Singapore General Hospital
Collaborators
Singapore Civil Defence Force
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1. Study Identification

Unique Protocol Identification Number
NCT02088736
Brief Title
Intraosseous vs Intravenous Access for Cardiac Arrest Treatment
Official Title
Clinical Evaluation of Intraosseous and Intravenous Access for Cardiac Arrest Treatment in Emergency Ambulances In Singapore
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 2014 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
Collaborators
Singapore Civil Defence Force

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous and Intraosseous
Arm Type
Active Comparator
Arm Description
'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.
Arm Title
Intravenous
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Intraosseous
Other Intervention Name(s)
EZIO
Intervention Type
Device
Intervention Name(s)
Intravenous
Other Intervention Name(s)
IV Cannula
Primary Outcome Measure Information:
Title
Any Return of Spontaneous Circulation Rate (ROSC)
Description
Any ROSC including transient or intermittent during pre- or in-hospital
Time Frame
At scene to hospital (about 2 hours)
Secondary Outcome Measure Information:
Title
Insertion success rate
Time Frame
90 secs
Title
Number of patients administered 1st dose
Time Frame
90 secs
Title
Survival outcome
Time Frame
up to 30 days
Title
Time taken for 1st dose of adrenaline given
Time Frame
90 secs

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Boon Kiat Tan, MBBS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Civil Defence Force
City
Singapore
Country
Singapore

12. IPD Sharing Statement

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Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

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