Intraosseous vs Intravenous Access for Cardiac Arrest Tre... | NCT02088736

Studies
Intraosseous vs Intravenous Access for Cardiac Arrest Treatment

NCT02088736

Sponsor

Singapore General Hospital

Status

Completed

Last Update Posted

Oct 28, 2019Actual

Enrollment

1,103Actual

Phase

Phase 4

Conditions

Cardiac Arrest

Interventions

Intraosseous
Intravenous

Countries

Singapore

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NMRC/CNIG/1110/2013	Other Identifier	MOH NMRC, Singapore

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014Actual

Primary Completion Date

Jan 2017Actual

Completion Date

Jun 2017Actual

First Submitted Date

Mar 11, 2014

First Submission Date that Met QC Criteria

Mar 13, 2014

First Posted Date

Mar 17, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 23, 2019

Last Update Posted Date

Oct 28, 2019Actual

Name	Class
Singapore Civil Defence Force	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,103Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Intraosseous	Device		Intravenous and Intraosseous	EZIO
Intravenous

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Insertion success rate		90 secs
Number of patients administered 1st dose		90 secs
Survival outcome

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kenneth Boon Kiat Tan, MBBS	Singapore General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Singapore Civil Defence Force		Singapore			Singapore

Condition Browse Module

MeSH Terms

ID	Term
D006323	Heart Arrest

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000072601	Cannula

Ancestor Terms

ID	Term
D057785	Catheters
D004864	Equipment and Supplies

Browse Leaves

Not provided

Browse Branches

Not provided