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

Tracking Information

• First Submitted Date: March 11, 2014
• First Posted Date: March 17, 2014
• Last Update Posted Date: October 28, 2019
• Actual Study Start Date: June 2014
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 23, 2019)

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

• Original Primary Outcome Measures (submitted: March 13, 2014): Return of Spontaneous Circulation Rate [ Time Frame: monitoring 10mins ]

Current Secondary Outcome Measures (submitted: March 13, 2014)

• Insertion success rate [ Time Frame: 90 secs ]
• Number of patients administered 1st dose [ Time Frame: 90 secs ]
• Survival outcome [ Time Frame: up to 30 days ]
• Time taken for 1st dose of adrenaline given [ Time Frame: 90 secs ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Cardiac Arrest

Intervention

• Device: Intraosseous
  Other Name: EZIO
• Device: Intravenous
  Other Name: IV Cannula

Study Arms

• 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.
  Intervention: Device: Intraosseous
• 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.
  Intervention: Device: Intravenous

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 9, 2018): 1103
• Original Estimated Enrollment (submitted: March 13, 2014): 400
• Actual Study Completion Date: June 2017
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Singapore

Administrative Information

• NCT Number: NCT02088736
• Other Study ID Numbers: CIRB 2013/676/C; NMRC/CNIG/1110/2013 ( Other Identifier: MOH NMRC, Singapore )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Singapore General Hospital
• Study Sponsor: Singapore General Hospital
• Collaborators: Singapore Civil Defence Force

Investigators

• Principal Investigator: Kenneth Boon Kiat Tan, MBBS; Singapore General Hospital

• PRS Account: Singapore General Hospital
• Verification Date: October 2019