Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

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

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
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.

Study Design

• 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

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 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

Outcome Measures

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 ]

Eligibility Criteria

• 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)

Contacts and Locations

Locations

Singapore

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

More Information

• 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
• Last Update Posted: October 28, 2019
• Last Verified: October 2019

Additional relevant MeSH terms:

Heart Arrest; Heart Diseases; Cardiovascular Diseases