Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

NCT02088736 | Completed Phase 4

• 2 other identifiers: CIRB 2013/676/CNMRC/CNIG/1110/2013
• Study Type: interventional
• Target: 1,103
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

• Any Return of Spontaneous Circulation Rate (ROSC)

  Any ROSC including transient or intermittent during pre- or in-hospital

  At scene to hospital (about 2 hours)

Secondary Outcomes (4)

• Insertion success rate

  90 secs

• Number of patients administered 1st dose

  90 secs

• Survival outcome

  up to 30 days

• Time taken for 1st dose of adrenaline given

  90 secs

Study Arms (2)

Intravenous and Intraosseous

ACTIVE COMPARATOR

'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

Intravenous

EXPERIMENTAL

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

Interventions

Intraosseous DEVICE

Also known as: EZIO

Intravenous and Intraosseous

Intravenous DEVICE

Also known as: IV Cannula

Intravenous

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiac arrest (medical or traumatic)
• Intravenous fluids or medications needed

You may not qualify if:

• Adult needle (weight ≥ 40 kg)
• Paediatric needle (weight 3 - 39 kg)

Sponsors & Collaborators

• Singapore General Hospital: lead
• Singapore Civil Defence Force: collaborator

Study Sites (1)

Singapore Civil Defence Force

Singapore, Singapore

Location

MeSH Terms

Conditions

Heart Arrest

Interventions

Cannula

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Kenneth Boon Kiat Tan, MBBS

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2014
• First Posted: March 17, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 28, 2019

Record last verified: 2019-10

Locations

SG (1)