Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

Cardiac Arrest Clinical Trial

Official title:

Clinical Evaluation of Intraosseous and Intravenous Access for Cardiac Arrest Treatment in Emergency Ambulances In Singapore

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02088736
• Other study ID #: CIRB 2013/676/C
• Secondary ID: NMRC/CNIG/1110/2
• Status: Completed
• Phase: Phase 4
• Start date: June 2014
• Est. completion date: June 2017

Study information

• Verified date: October 2019
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1103
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Device:
• Intraosseous

• Intravenous

Locations

Country	Name	City	State
Singapore	Singapore Civil Defence Force	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Singapore General Hospital	Singapore Civil Defence Force

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Insertion success rate		90 secs
Secondary	Number of patients administered 1st dose		90 secs
Secondary	Survival outcome		up to 30 days
Secondary	Time taken for 1st dose of adrenaline given		90 secs